The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Duo Derm Flex Hydroactive Dressings &.
| Device ID | K830708 |
| 510k Number | K830708 |
| Device Name: | DUO DERM FLEX HYDROACTIVE DRESSINGS & |
| Classification | Dressing, Wound, Drug |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| 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 | 1983-03-07 |
| Decision Date | 1983-05-05 |