510(k) K081633 ยท FXX Mask, Surgical
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
| Applicant | Primed Medical Products, Inc., Edmonton, Alberta, CA |
| Decision | Substantially Equivalent, Aug 11, 2008 |
| Received | Jun 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081633
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.