K110744 is an FDA 510(k) clearance for the PRONTOSAN WOUND IRRIGATION SOLUTION. This device is classified as a Dressing, Wound, Drug.
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on April 6, 2011, 20 days after receiving the submission on March 17, 2011.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K110744 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2011 |
| Decision Date | April 06, 2011 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |