510(k) K001951 ยท FXX Mask, Surgical
PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
| Applicant | Primeline Medical Products, Inc., Edmonton, Alberta, CA |
| Decision | Substantially Equivalent, Sep 8, 2000 |
| Received | Jun 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001951
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.