The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Durahesive Wafer With Flange.
| Device ID | K855018 |
| 510k Number | K855018 |
| Device Name: | DURAHESIVE WAFER WITH FLANGE |
| Classification | Collector, Ostomy |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Contact | Peter C Kallos |
| Correspondent | Peter C Kallos CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-02-04 |