Date Received: 1978-01-09

Decision Date: 1978-02-21

Contact:

Address:

City: McHenry

State: IL

Product Code: FMW

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: General Hospital

Advisory Committee Code under which the product was classified: HO

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-11-01

Decision Date: 1977-12-20

Contact:

Address:

City: McHenry

State: IL

Product Code: ETD

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Ear, Nose, Throat

Advisory Committee Code under which the product was classified: EN

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-10-06

Decision Date: 1977-10-19

Contact:

Address:

City: McHenry

State: IL

Product Code: IYE

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Radiology

Advisory Committee Code under which the product was classified: RA

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-10-03

Decision Date: 1977-11-28

Contact:

Address:

City: McHenry

State: IL

Product Code: FSY

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: General, Plastic Surgery

Advisory Committee Code under which the product was classified: SU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-09-12

Decision Date: 1977-10-18

Contact:

Address:

City: McHenry

State: IL

Product Code: JJW

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Clinical Chemistry

Advisory Committee Code under which the product was classified: CH

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-08-11

Decision Date: 1977-10-07

Contact:

Address:

City: McHenry

State: IL

Product Code: KYX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: General Hospital

Advisory Committee Code under which the product was classified: HO

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-08-10

Decision Date: 1977-08-26

Contact:

Address:

City: McHenry

State: IL

Product Code: BWF

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Anesthesiology

Advisory Committee Code under which the product was classified: AN

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-07-07

Decision Date: 1977-08-16

Contact:

Address:

City: McHenry

State: IL

Product Code: DQX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Cardiovascular

Advisory Committee Code under which the product was classified: CV

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-06-02

Decision Date: 1977-06-17

Contact:

Address:

City: McHenry

State: IL

Product Code: HTZ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: General, Plastic Surgery

Advisory Committee Code under which the product was classified: SU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-05-31

Decision Date: 1977-06-20

Contact:

Address:

City: McHenry

State: IL

Product Code: NYH

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Dental

Advisory Committee Code under which the product was classified: DE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-05-25

Decision Date: 1977-08-02

Contact:

Address:

City: McHenry

State: IL

Product Code: JJS

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Clinical Chemistry

Advisory Committee Code under which the product was classified: HE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-05-03

Decision Date: 1977-05-20

Contact:

Address:

City: McHenry

State: IL

Product Code: GQX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Microbiology

Advisory Committee Code under which the product was classified: IM

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-05-02

Decision Date: 1977-07-05

Contact:

Address:

City: McHenry

State: IL

Product Code: GKK

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Hematology

Advisory Committee Code under which the product was classified: CH

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-04-22

Decision Date: 1977-06-23

Contact:

Address:

City: McHenry

State: IL

Product Code: JSE

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Microbiology

Advisory Committee Code under which the product was classified: MI

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1977-03-21

Decision Date: 1977-04-15

Contact:

Address:

City: McHenry

State: IL

Product Code: FZT

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: General, Plastic Surgery

Advisory Committee Code under which the product was classified: SU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1976-11-19

Decision Date: 1976-12-02

Contact:

Address:

City: McHenry

State: IL

Product Code: GWX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Neurology

Advisory Committee Code under which the product was classified: NE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1976-07-26

Decision Date: 1976-08-11

Contact:

Address:

City: HAMMONTON

State: NJ

Product Code: FSE

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: General, Plastic Surgery

Advisory Committee Code under which the product was classified: SU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1976-07-12

Decision Date: 1976-08-11

Contact:

Address:

City: McHenry

State: IL

Product Code: KKX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: General, Plastic Surgery

Advisory Committee Code under which the product was classified: HO

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1976-07-09

Decision Date: 1976-07-26

Contact:

Address:

City: McHenry

State: IL

Product Code: DHN

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Immunology

Advisory Committee Code under which the product was classified: IM

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

Date Received: 1976-06-28

Decision Date: 1976-10-07

Contact:

Address:

City: McHenry

State: IL

Product Code: FCM

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Gastroenterology, Urology

Advisory Committee Code under which the product was classified: GU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review: