K091034 is an FDA 510(k) clearance for the AQUACEL AG SURGICAL, a Dressing, Wound, Drug, submitted by Convatec (Skillman, US). The FDA issued a Cleared decision on December 16, 2009, 250 days after receiving the submission on April 10, 2009. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K091034 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 10, 2009 |
| Decision Date | December 16, 2009 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |