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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, incontinence, urosheath type, sterile
510(k) Number K972100
Device Name VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)
Applicant
ADVANCED CARE MEDICAL PRODUCTS
385 BEL MARIN KEYS BLVD. #J
NOVATO,  CA  94949
Applicant Contact STEVEN FAINSZTEIN
Correspondent
ADVANCED CARE MEDICAL PRODUCTS
385 BEL MARIN KEYS BLVD. #J
NOVATO,  CA  94949
Correspondent Contact STEVEN FAINSZTEIN
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received06/04/1997
Decision Date 07/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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