K050086 is an FDA 510(k) clearance for the BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING. This device is classified as a Dressing, Wound, Drug.
Submitted by Brennen Medical, Inc. (St, Paul, US). The FDA issued a Cleared decision on February 17, 2006, 400 days after receiving the submission on January 13, 2005.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K050086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2005 |
| Decision Date | February 17, 2006 |
| Days to Decision | 400 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |