The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Sur-fit Urostomy Pouch W/accuseal.
| Device ID | K840166 |
| 510k Number | K840166 |
| Device Name: | SUR-FIT UROSTOMY POUCH W/ACCUSEAL |
| Classification | Collector, Ostomy |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-16 |
| Decision Date | 1984-02-04 |