K100839 is an FDA 510(k) clearance for the BARIREP. This device is classified as a Dressing, Wound, Drug.
Submitted by Gorbec Pharmaceutical Services, Inc. (Durham, US). The FDA issued a Cleared decision on May 11, 2010, 48 days after receiving the submission on March 24, 2010.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K100839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2010 |
| Decision Date | May 11, 2010 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |