K083007 is an FDA 510(k) clearance for the PROWICK. This device is classified as a Dressing, Wound, Drug.
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 8, 2009, 182 days after receiving the submission on October 8, 2008.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K083007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2008 |
| Decision Date | April 08, 2009 |
| Days to Decision | 182 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |