510(k) K964114 ยท FXX Mask, Surgical
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
| Applicant | Depuy, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 6, 1997 |
| Received | Oct 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964114
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.