510(k) K011789 ยท FXX Mask, Surgical
PROCEDURE MASKS: PM4-301 AND PM4-304
| Applicant | Primeline Medical Products, Inc., Edmonton, Alberta, CA |
| Decision | Substantially Equivalent, Jun 22, 2001 |
| Received | Jun 8, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011789
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.