CPR URINE BAG— 510(k) K960217

Substantially Equivalent

Custom Pack Reliability

FDA 510(k) clearance K960217 for CPR URINE BAG, Substantially Equivalent on 1996-03-28. Applicant: Custom Pack Reliability. Device class: 1.

Clearance details

Applicant: Custom Pack Reliability
Product code: Code FAQ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1996-01-16
Decision date: 1996-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAQ

K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING1996-07-18
K955609 — CONVEEN URINE BAG - STERILE1995-12-29
K953767 — PROSYS BEDSIDE DRAINAGE BAG1995-12-20
K953783 — CONVEEN LEG BAG STRAP1995-09-13
K951945 — PROSYS LEG BAG1995-05-25

More clearances from Custom Pack Reliability

K960205 — CPR TRACHEOTOMY CARE TRAY1996-08-27
K960239 — CPR D & C TRAY1996-05-23
K960243 — CPR C-SECTION DELIVERY PACK1996-05-23
K960216 — CPR SUCTION CATHETER KIT1996-04-15
K960206 — CPR DRESSING CHANGE TRAY1996-04-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.