510(k) K922627 ยท NPK Barrier, Synthetic, Intraoral
GORE-TEX REGENERATIVE MATERIAL
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Jun 10, 1994 |
| Received | Jun 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922627
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.