FDA 510(k) Application Details - K972100

Device Classification Name	Device, Incontinence, Urosheath Type, Sterile   More FDA Info for this Device
510(K) Number	K972100
Device Name	Device, Incontinence, Urosheath Type, Sterile
Applicant	ADVANCED CARE MEDICAL PRODUCTS 385 BEL MARIN KEYS BLVD. #J NOVATO, CA 94949 US Other 510(k) Applications for this Company
Contact	STEVEN FAINSZTEIN Other 510(k) Applications for this Contact
Regulation Number	876.5250   More FDA Info for this Regulation Number
Classification Product Code	EXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/1997
Decision Date	07/31/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review