K063835 is an FDA 510(k) clearance for the ALLEVYN AG DRESSING. This device is classified as a Dressing, Wound, Drug.
Submitted by Smith & Nephew, Inc. (Largo, US). The FDA issued a Cleared decision on August 3, 2007, 220 days after receiving the submission on December 26, 2006.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K063835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2006 |
| Decision Date | August 03, 2007 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |