K122325 is an FDA 510(k) clearance for the SKINTEMP II. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Human Biosciences, Inc. (Oak Grove, US). The FDA issued a Cleared decision on October 26, 2012, 86 days after receiving the submission on August 1, 2012.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K122325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2012 |
| Decision Date | October 26, 2012 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN - Wound Dressing With Animal-derived Material(s) |
| Device Class | - |