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510(k) Number K014068 For ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 From W & H DENTALWERK BUERMOOS GMBH

Date Received: 2001-12-10

Decision Date: 2002-05-03

Contact: RALF BENDA

Address:

City: BUERMOOS

State:

Product Code: EBW

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Dental

Advisory Committee Code under which the product was classified: DE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K014048 For CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS From CLINICON CORP.

Date Received: 2001-12-07

Decision Date: 2002-02-11

Contact: SEAN M CURRY

Address:

City: SAN DIEGO

State: CA

Product Code: GEX

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: SU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K981272 For ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES From ELECTRO THERAPEUTIC DEVICES, INC.

Date Received: 1998-04-07

Decision Date: 1998-08-24

Contact: K C CHOONG

Address:

City: MARKHAM, ONTARIO

State:

Product Code: MQX

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 K981190 For HIGH IMPEDANCE CARDIAC GATING CABLE From GE MEDICAL SYSTEMS

Date Received: 1998-04-02

Decision Date: 1998-06-30

Contact: LARRY KROGER

Address:

City: MILWAUKEE

State: WI

Product Code: LNH

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 K980946 For MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP From DENTSLEEVE PTY., LTD.

Date Received: 1998-03-13

Decision Date: 1998-06-08

Contact: MARCUS TIPPETT

Address:

City: PARKSIDE SOUTH AUSTRALIA

State:

Product Code: FFX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: 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:

510(k) Number K980711 For HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING From ZIMMER, INC.

Date Received: 1998-02-24

Decision Date: 1998-11-12

Contact: RUTH ANN WOOD

Address:

City: WARSAW

State: IN

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 K980407 For HOPE NEBULIZER From B & B MEDICAL TECHNOLOGIES, INC.

Date Received: 1998-02-03

Decision Date: 1998-05-27

Contact: STEPHEN W BRIGGS III

Address:

City: RANCHO CORDOVA

State: CA

Product Code: CAF

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Statement

Advisory Committee: Anesthesiology

Advisory Committee Code under which the product was classified: AN

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K974493 For FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES From FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH

Date Received: 1997-11-28

Decision Date: 1998-03-31

Contact:

Address:

City: TUTTLINGEN

State:

Product Code: FDS

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Statement

Advisory Committee: Gastroenterology, Urology

Advisory Committee Code under which the product was classified: GU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K974442 For PRE-POWDERED NITRILE EXAMINATION GLOVES From P.T. LATEXINDO TOBAPERKASA

Date Received: 1997-11-25

Decision Date: 1998-01-05

Contact: HENDRA RAMALI

Address:

City: MEDAN

State:

Product Code: LZY

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Statement

Advisory Committee: Orthopedic

Advisory Committee Code under which the product was classified: HO

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K974458 For COMPOLUTE APLICAP From ESPE DENTAL-MEDIZIN GMBH & CO.KG.

Date Received: 1997-11-25

Decision Date: 1998-02-02

Contact: BARBARA WAGNER-SCHUH

Address:

City: SEEFELD

State:

Product Code: EMA

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Dental

Advisory Committee Code under which the product was classified: DE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number/Type	Applicant	Device	Advisory Committe	Date Received	Decision Date	More Info
K014068	W & H DENTALWERK BUERMOOS GMBH	ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115	Dental	2001-12-10	2002-05-03
K014048	CLINICON CORP.	CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS	General, Plastic Surgery	2001-12-07	2002-02-11
K981272	ELECTRO THERAPEUTIC DEVICES, INC.	ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES	General Hospital	1998-04-07	1998-08-24
K981190	GE MEDICAL SYSTEMS	HIGH IMPEDANCE CARDIAC GATING CABLE	Radiology	1998-04-02	1998-06-30
K980946	DENTSLEEVE PTY., LTD.	MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP	Gastroenterology, Urology	1998-03-13	1998-06-08
K980711	ZIMMER, INC.	HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING	Orthopedic	1998-02-24	1998-11-12
K980407	B & B MEDICAL TECHNOLOGIES, INC.	HOPE NEBULIZER	Anesthesiology	1998-02-03	1998-05-27
K974493	FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH	FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES	Gastroenterology, Urology	1997-11-28	1998-03-31
K974442	P.T. LATEXINDO TOBAPERKASA	PRE-POWDERED NITRILE EXAMINATION GLOVES	Orthopedic	1997-11-25	1998-01-05
K974458	ESPE DENTAL-MEDIZIN GMBH & CO.KG.	COMPOLUTE APLICAP	Dental	1997-11-25	1998-02-02

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