510(k) K942280 ยท FWP Prosthesis, Chin, Internal
GORETEX SAM FACIAL IMPLANT
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jul 28, 1994 |
| Received | May 10, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942280
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.