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
K924407 COLOPLAST A/S CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH 09/23/1992
K946243 COLOPLAST A/S CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER 02/13/1995
K942941 CONVATEC, A BRISTOL-MYERS SQUIBB CO. CONQUEST MALE CONTINENCE SYSTEM 03/17/1995
K963265 CONVATEC, A DIVISION OF E.R. SQUIBB & SONS PROSYS SAMEC LA 10/25/1996
K950690 CONVATEC, A DIVISION OF E.R. SQUIBB & SONS PROSYS URIHESICE SYSTEM NL 03/23/1995
K951530 CONVATEC, A DIVISION OF E.R. SQUIBB & SONS PROSYS URIHESIVE SYSTEM LA 05/12/1995
K851682 DBT MEDICAL LTD. SAFESEAL REUSABLE URINAL SYSTEM 06/24/1985
K970465 GENERAL POLYMERS BOUSER'S URINAL 12/18/1997
K940269 HOLLISTER, INC. HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER 06/02/1994
K962900 HOLLISTER, INC. SELF RETAINING MALE EXTERNAL URINARY CATHETER 09/16/1996
K903715 MARK SULLIVAN, M.D., P.C. CONDOM SEAL 01/23/1991
K772144 MEDLINE INDUSTRIES, INC. CATHETER, DISP., EXTERNAL, MALE 11/28/1977
K945628 MENTOR CORP. CLEAR ADVANTAGE II 07/06/1995
K913524 MENTOR CORP. SILICONE MALE EXTERNAL CATHETER 10/04/1991
K923136 ROCHESTER MEDICAL CORP. MALE EXTERNAL CATHETER 12/03/1992
K952082 ROCHESTER MEDICAL CORP. ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER 07/18/1995
K970966 SIERRA LABORATORIES, INC. COMFORT CATH CHOICE MALE EXTERNAL CATHETER 04/22/1997
K934266 SIERRA LABORATORIES, INC. COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER 04/19/1994
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
K931156 SIERRA LABORATORIES, INC. CONE CATH 07/01/1993


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