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510(k) Number K890653 For ULTIMA WHEELCHAIR CUSHION From CLARK PILLOW CO., INC.

Date Received: 1989-02-08

Decision Date: 1989-02-28

Contact: PAUL M GUILBEAU

Address:

City: BEAUMONT

State: TX

Product Code: IMP

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Physical Medicine

Advisory Committee Code under which the product was classified: PM

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K885306 For NUPREP From WEAVER & CO.

Date Received: 1988-12-27

Decision Date: 1989-02-23

Contact: DOUGLAS T CLEVELAND

Address:

City: AURORA

State: CO

Product Code: DRX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Cardiovascular

Advisory Committee Code under which the product was classified: AN

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K885110 For PROTEUS OX-19 IFA* From INVESTIGACION FARMACEUTICA S.A. DE C.V.

Date Received: 1988-12-12

Decision Date: 1989-08-15

Contact: SMITHERS HOGG.

Address:

City: MEXICO

State:

Product Code: GSZ

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:

510(k) Number K885083 For INFUSA-PLATE(TM) EX From KALAYJIAN ENT.

Date Received: 1988-12-09

Decision Date: 1989-02-27

Contact: W KALAYJIAN

Address:

City: LONG BEACH

State: CA

Product Code: FRN

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:

510(k) Number K884893 For CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 From AMERICAN OMNI MEDICAL, INC.

Date Received: 1988-11-22

Decision Date: 1989-01-30

Contact: GEORGE G SIPOSS

Address:

City: COSTA MESA

State: CA

Product Code: KRI

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:

510(k) Number K884694 For MQL 20 ND:YAG OPHTHALMIC LASER From CALIFORNIA LABORATORIES, INC.

Date Received: 1988-11-09

Decision Date: 1988-11-30

Contact: KENNETH R MICHAEL

Address:

City: CARLSBAD

State: CA

Product Code: LQJ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Ophthalmic

Advisory Committee Code under which the product was classified: SU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K884553 For STAMEY NEEDLE From COOK OB/GYN

Date Received: 1988-10-31

Decision Date: 1988-11-14

Contact: MICHELLE YOUNG

Address:

City: SPENCER

State: IN

Product Code: GEJ

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:

510(k) Number K884272 For WOODEN SPECTACLE FRAMES From WOODWAVE

Date Received: 1988-10-12

Decision Date: 1988-12-12

Contact: DARIENNE MOYER

Address:

City: WASHINGTON

State: DC

Product Code: HQZ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Ophthalmic

Advisory Committee Code under which the product was classified: OP

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K884029 For KTP/532 SURGICAL LASER From LASERSCOPE

Date Received: 1988-09-23

Decision Date: 1988-11-25

Contact: RICHARD P RUDY

Address:

City: SAN JOSE

State: CA

Product Code: GEX

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:

510(k) Number K860488 For OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915 From CAS MEDICAL SYSTEMS, INC.

Date Received: 1986-02-10

Decision Date: 1986-08-25

Contact: COHEN, PHD

Address:

City: BRANFORD

State: CT

Product Code: DXN

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:

510(k) Number/Type	Applicant	Device	Advisory Committe	Date Received	Decision Date	More Info
K890653	CLARK PILLOW CO., INC.	ULTIMA WHEELCHAIR CUSHION	Physical Medicine	1989-02-08	1989-02-28
K885306	WEAVER & CO.	NUPREP	Cardiovascular	1988-12-27	1989-02-23
K885110	INVESTIGACION FARMACEUTICA S.A. DE C.V.	PROTEUS OX-19 IFA*	Microbiology	1988-12-12	1989-08-15
K885083	KALAYJIAN ENT.	INFUSA-PLATE(TM) EX	General Hospital	1988-12-09	1989-02-27
K884893	AMERICAN OMNI MEDICAL, INC.	CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25	Cardiovascular	1988-11-22	1989-01-30
K884694	CALIFORNIA LABORATORIES, INC.	MQL 20 ND:YAG OPHTHALMIC LASER	Ophthalmic	1988-11-09	1988-11-30
K884553	COOK OB/GYN	STAMEY NEEDLE	General, Plastic Surgery	1988-10-31	1988-11-14
K884272	WOODWAVE	WOODEN SPECTACLE FRAMES	Ophthalmic	1988-10-12	1988-12-12
K884029	LASERSCOPE	KTP/532 SURGICAL LASER	General, Plastic Surgery	1988-09-23	1988-11-25
K860488	CAS MEDICAL SYSTEMS, INC.	OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915	Cardiovascular	1986-02-10	1986-08-25

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