510(k) K160361 ยท FYC Gown, Isolation, Surgical
PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
| Applicant | Primed Medical Products, Inc., Edmonton, CA |
| Decision | Substantially Equivalent, Nov 4, 2016 |
| Received | Feb 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160361
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.