510(k) K092012 ยท FXX Mask, Surgical
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
| Applicant | Primed Medical Products, Inc., Edmonton, Alberta, CA |
| Decision | Substantially Equivalent, Sep 25, 2009 |
| Received | Jul 6, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092012
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.