K152600 is an FDA 510(k) clearance for the Collagen Dental Wound Dressings. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on June 23, 2016, 286 days after receiving the submission on September 11, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K152600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2015 |
| Decision Date | June 23, 2016 |
| Days to Decision | 286 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 | — |