The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons, L.l.c. with the FDA for Aquacel Hydrofiber Wound Dressing And Ag Hydrofiber Dressing.
| Device ID | K080383 |
| 510k Number | K080383 |
| Device Name: | AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Marilyn Konicky |
| Correspondent | Marilyn Konicky CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 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 | Yes |
| Date Received | 2008-02-12 |
| Decision Date | 2008-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455145621 | K080383 | 000 |
| 10768455106742 | K080383 | 000 |