510(k) K102971 ยท FYA Gown, Surgical
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
| Applicant | Microtek Medical, Inc., Columbus MS, US |
| Decision | Substantially Equivalent, Feb 23, 2011 |
| Received | Oct 6, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102971
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.