The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Duoderm Flexible Hydroactive Dressings.
| Device ID | K821656 |
| 510k Number | K821656 |
| Device Name: | DUODERM FLEXIBLE HYDROACTIVE DRESSINGS |
| Classification | Dressing, Wound, Drug |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 | 1982-06-04 |
| Decision Date | 1982-09-07 |