510(k) K946343 ยท FXX Mask, Surgical
INTEC EXTENDED EYE SHIELD WITH MASK
| Applicant | Intec Industries, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Mar 22, 1995 |
| Received | Dec 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946343
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.