The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Dermasorb Wound Contact Layer Dressing.
| Device ID | K903645 |
| 510k Number | K903645 |
| Device Name: | DERMASORB WOUND CONTACT LAYER DRESSING |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| 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 | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-14 |
| Decision Date | 1990-11-21 |