The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Duoderm* Control Gel Formula Border Dressing.
| Device ID | K901155 |
| 510k Number | K901155 |
| Device Name: | DUODERM* CONTROL GEL FORMULA BORDER DRESSING |
| Classification | Bandage, Liquid |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Contact | B Dreyling |
| Correspondent | B Dreyling CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-13 |
| Decision Date | 1990-04-16 |