The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Duoderm Hydroactive Dressing And Cgf Dressings.
| Device ID | K912667 |
| 510k Number | K912667 |
| Device Name: | DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| 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 | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1991-09-04 |