The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Duoderm Dressings, Cgf Dressings, Paste Full Thick.
| Device ID | K904852 |
| 510k Number | K904852 |
| Device Name: | DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK |
| Classification | Dressing, Wound, Drug |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Contact | Marilyn B Dreyling |
| Correspondent | Marilyn B Dreyling CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-29 |
| Decision Date | 1991-01-25 |