510(k) K152600 ยท KGN Wound Dressing With Animal-Derived Material(S)
Collagen Dental Wound Dressings
| Applicant | Collagen Matrix, Inc., Oakland NJ, US |
| Decision | Substantially Equivalent, Jun 23, 2016 |
| Received | Sep 11, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152600
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2022 | Collagen Matrix Inc Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm
Product was distributed under the following brand names:
1) Cytoplast RTMTAPE, 25mm x 75mm
2) GIBSON Healthcare, 25mm x 75mm
3) Maxx Open, Classified |
KGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.