510(k) K011695 ยท NPL Barrier, Animal Source, Intraoral
COLLAGEN DENTAL MEMBRANE
| Applicant | Collagen Matrix, Inc., Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Aug 7, 2001 |
| Received | May 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011695
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2019 | Collagen Matrix, Inc. Neomem Resorbable Collagen Membrane, 15 mm x 20 mm
Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery Terminated |
NPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.