The following data is part of a premarket notification filed by E. R. Squibb & Sons, Inc. with the FDA for Sur-fit Urostomy Pouch & Urinary Bag.
| Device ID | K800495 |
| 510k Number | K800495 |
| Device Name: | SUR-FIT UROSTOMY POUCH & URINARY BAG |
| Classification | Collector, Ostomy |
| Applicant | E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York, NY 10019 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-04 |
| Decision Date | 1980-04-08 |