510(k) K984534 ยท GXQ Dura Substitute
PRECLUDE ACUSEAL DURA SUBSTITUTE
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Mar 15, 1999 |
| Received | Dec 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984534
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.