K073251 is an FDA 510(k) clearance for the HYALOMATRIX PA. This device is classified as a Absorbable Synthetic Wound Dressing.
Submitted by Fidia Advanced Biopolymers Srl (Washington, US). The FDA issued a Cleared decision on December 14, 2007, 25 days after receiving the submission on November 19, 2007.
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 | K073251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2007 |
| Decision Date | December 14, 2007 |
| Days to Decision | 25 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. |