510(k) K132386 ยท FYA Gown, Surgical
TOTALSHIELD SURGICAL HELMET SYSTEM
| Applicant | Zimmer, Inc., Indianpolis IN, US |
| Decision | Substantially Equivalent, Dec 23, 2013 |
| Received | Aug 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132386
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.