510(k) K961802 ยท GXO Strip, Craniosynostosis, Preformed
PRECLUDE SYNBLOC MEMBRANE
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Jul 31, 1996 |
| Received | May 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961802
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.