The following data is part of a premarket notification filed by Convatec with the FDA for Aquacel Ag Surgical.
| Device ID | K091034 |
| 510k Number | K091034 |
| Device Name: | AQUACEL AG SURGICAL |
| Classification | Dressing, Wound, Drug |
| Applicant | CONVATEC 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Patricia Kearins |
| Correspondent | Patricia Kearins CONVATEC 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 | 2009-04-10 |
| Decision Date | 2009-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455125104 | K091034 | 000 |
| 00768455124305 | K091034 | 000 |
| 00768455124299 | K091034 | 000 |
| 00768455124282 | K091034 | 000 |
| 00768455124275 | K091034 | 000 |