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510(k) Number K062858 For MODIFICATION TO GLIDESHEATH From TERUMO MEDICAL CORP.

Date Received: 2006-09-25

Decision Date: 2006-10-20

Contact: MARK UNTERREINER

Address:

City: Elkton

State: MD

Product Code: DYB

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: 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 K062704 For STERILIZATION POUCH WITH INDICATORS From WINNER INDUSTRIES (SHENZHEN) CO., LTD.

Date Received: 2006-09-11

Decision Date: 2007-06-08

Contact: MING XIE

Address:

City: POMONA

State: CA

Product Code: FRG

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: 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 K062621 For NIO 5MP-21 AND MDNG-5121 CB From BARCOVIEW

Date Received: 2006-09-05

Decision Date: 2007-03-19

Contact: LIEVEN DE WANDEL

Address:

City: KORTRIJK

State:

Product Code: LLZ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Radiology

Advisory Committee Code under which the product was classified: RA

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K062489 For APEX HCLA ACETABULAR CUP LINERS From OMNILIFE SCIENCE

Date Received: 2006-08-25

Decision Date: 2007-08-15

Contact: EDWARD CHEAL

Address:

City: RAYNHAM

State: MA

Product Code: LPH

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Orthopedic

Advisory Committee Code under which the product was classified: OR

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K062480 For JOYKEY SURGICAL DRAPES (STERILE) From JOYKEY INDUSTRYIAL LTD.

Date Received: 2006-08-24

Decision Date: 2007-03-05

Contact: JENNIFER REICH

Address:

City: FLAGSTAFF

State: AZ

Product Code: KKX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: 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:

510(k) Number K062325 For RS-4I MUSCLE STIMULATOR FAMILY From RS MEDICAL

Date Received: 2006-08-09

Decision Date: 2007-04-13

Contact: STEVEN CHERNOFF

Address:

City: REDMOND

State: WA

Product Code: NYN

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Neurology

Advisory Committee Code under which the product was classified: SU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K925695 For OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD From OSTEONICS CORP.

Date Received: 1992-11-12

Decision Date: 1993-04-20

Contact: ROBERT A KOCH

Address:

City: ALLENDALE

State: NJ

Product Code: LZO

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Orthopedic

Advisory Committee Code under which the product was classified: OR

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K880440 For PROTECT-AIDS AUTOPSY UNDERGLOVE From MEDICAL ARMOR CORP.

Date Received: 1988-02-02

Decision Date: 1988-10-11

Contact: DWIGHT K GAHM

Address:

City: MINNEAPOLIS

State: MN

Product Code: LYU

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 K880340 For MODIFIED AIR FLUIDIZED BED, KINAIR From KINETIC CONCEPTS, INC.

Date Received: 1988-01-26

Decision Date: 1988-02-16

Contact: WEHRMEYER, JR

Address:

City: SAN ANTONIO

State: TX

Product Code: INX

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 K860049 For DETERMINATION OF QUINIDINE From CLINICAL DATA, INC.

Date Received: 1986-01-06

Decision Date: 1986-01-22

Contact: ISRAEL M STEIN,M.D.

Address:

City: BOSTON

State: MA

Product Code: LBZ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Clinical Toxicology

Advisory Committee Code under which the product was classified: TX

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number/Type	Applicant	Device	Advisory Committe	Date Received	Decision Date	More Info
K062858	TERUMO MEDICAL CORP.	MODIFICATION TO GLIDESHEATH	Cardiovascular	2006-09-25	2006-10-20
K062704	WINNER INDUSTRIES (SHENZHEN) CO., LTD.	STERILIZATION POUCH WITH INDICATORS	General Hospital	2006-09-11	2007-06-08
K062621	BARCOVIEW	NIO 5MP-21 AND MDNG-5121 CB	Radiology	2006-09-05	2007-03-19
K062489	OMNILIFE SCIENCE	APEX HCLA ACETABULAR CUP LINERS	Orthopedic	2006-08-25	2007-08-15
K062480	JOYKEY INDUSTRYIAL LTD.	JOYKEY SURGICAL DRAPES (STERILE)	General, Plastic Surgery	2006-08-24	2007-03-05
K062325	RS MEDICAL	RS-4I MUSCLE STIMULATOR FAMILY	Neurology	2006-08-09	2007-04-13
K925695	OSTEONICS CORP.	OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD	Orthopedic	1992-11-12	1993-04-20
K880440	MEDICAL ARMOR CORP.	PROTECT-AIDS AUTOPSY UNDERGLOVE	General, Plastic Surgery	1988-02-02	1988-10-11
K880340	KINETIC CONCEPTS, INC.	MODIFIED AIR FLUIDIZED BED, KINAIR	Physical Medicine	1988-01-26	1988-02-16
K860049	CLINICAL DATA, INC.	DETERMINATION OF QUINIDINE	Clinical Toxicology	1986-01-06	1986-01-22

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