The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Signadress Duoderm Dressing.
| Device ID | K990964 |
| 510k Number | K990964 |
| Device Name: | SIGNADRESS DUODERM DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Nancy L Wolley |
| Correspondent | Nancy L Wolley CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-23 |
| Decision Date | 1999-05-18 |
| Summary: | summary |