510(k) K963568 ยท FXX Mask, Surgical
MASK SURGICAL
| Applicant | The Innovative Approach, Corp., Hato Rey PR, US |
| Decision | Substantially Equivalent, Feb 25, 1997 |
| Received | Sep 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963568
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.