K101882 is an FDA 510(k) clearance for the PRONTOSAN ANTIMICROBIAL WOUND GEL. This device is classified as a Dressing, Wound, Drug.
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 3, 2010, 120 days after receiving the submission on July 6, 2010.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K101882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2010 |
| Decision Date | November 03, 2010 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |