K142879 is an FDA 510(k) clearance for the BTM Wound Dressing. This device is classified as a Absorbable Synthetic Wound Dressing.
Submitted by Polynovo Biomaterials Pty, Ltd. (Port Melbourne, AU). The FDA issued a Cleared decision on December 23, 2015, 447 days after receiving the submission on October 2, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application..
| 510(k) Number | K142879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2014 |
| Decision Date | December 23, 2015 |
| Days to Decision | 447 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSZ - Absorbable Synthetic Wound Dressing |
| Device Class | - |
| Definition | Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application. |