510(k) K971509 ยท NWA Prosthesis, Tracheal, Preformed/Molded
ENDOXANE
| Applicant | Novatech SA, Aubagne, FR |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Aug 21, 1997 |
| Received | Apr 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971509
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.