FDA 510(k) Applications for Medical Device Product Code: EXJ (Device, Incontinence, Urosheath Type, Sterile)

FDA 510(k) Applications for Medical Device Product Code "EXJ"
(Device, Incontinence, Urosheath Type, Sterile)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K972100	ADVANCED CARE MEDICAL PRODUCTS	VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)	07/31/1997
K963265	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS	PROSYS SAMEC LA	10/25/1996
K970465	GENERAL POLYMERS	BOUSER'S URINAL	12/18/1997
K962900	HOLLISTER, INC.	SELF RETAINING MALE EXTERNAL URINARY CATHETER	09/16/1996
K970966	SIERRA LABORATORIES, INC.	COMFORT CATH CHOICE MALE EXTERNAL CATHETER	04/22/1997
K962413	SIERRA LABORATORIES, INC.	COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER	07/15/1996
K962384	SIERRA LABORATORIES, INC.	COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER	07/15/1996