510(k) K171645 ยท KGN Wound Dressing With Animal-Derived Material(S)
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
| Applicant | Strukmyer Medical, Mesquite TX, US |
| Decision | Substantially Equivalent, Jul 25, 2017 |
| Received | Jun 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171645
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E Open, Classified |
KGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.