FDA 510(k) Applications for Medical Device Product Code "EYZ"
(System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile)

FDA 510(k) Number Applicant Device Name Decision Date
K890465 CYPRESS MEDICAL PRODUCTS, LTD. CLOSED SYSTEM URINARY DRAINAGE BAG 05/23/1989
K930556 EZMT VALVE CO., INC. NIGHT URINARY DRAINAGE BEDSIDE BAG 05/14/1993
K964219 GOULTER MEDICAL, INC. ZIP CONDOM CATHETER 08/11/1997
K951597 KEY MEDICAL SERVICES, INC. URINARY DRAINAGE BAG 08/04/1995
K780267 LATEX IND., INC. CATH TRAY W/OUT CATHETER 02/24/1978
K882714 LSL INDUSTRIES, INC. URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 01/31/1989
K896695 MEDLINE INDUSTRIES, INC. DYNA-FLO URINARY DRAINAGE BAG 05/02/1990
K952780 P.A.M., INC. URINARY GEL DRAINAGE SYSTEM 12/12/1995
K933126 PATSY J. TRISLER, J.D. COMFORTCARE SYSTEM 02/25/1994
K942753 RESEARCHED, NOVEL MEDICAL DEVICES (RN/MD) ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER 11/02/1994
K901000 SIERRA LABORATORIES, INC. URO TEX URINALS 03/26/1990
K961906 SPECTRUM MEDSYSTEMS CORP. UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 11/19/1996
K891178 TECNOL NEW JERSEY WOUND CARE, INC. TECNOL SECURE-ALL TUBE HOLDER 05/23/1989
K772113 TRAVENOL LABORATORIES, S.A. URINARY DRAINAGE BAG 2D9017 11/16/1977


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact