The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Absorbent Antimicrobial Wound Dressing.
| Device ID | K013814 |
| 510k Number | K013814 |
| Device Name: | ABSORBENT ANTIMICROBIAL WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Demetrios Kydonieus |
| Correspondent | Demetrios Kydonieus CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| 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 | 2001-11-16 |
| Decision Date | 2002-06-21 |
| Summary: | summary |