510(k) K192194 ยท FYA Gown, Surgical
TotalShield II Surgical Helmet System
| Applicant | Zimmer Surgical, Inc., Dover OH, US |
| Decision | Substantially Equivalent, Oct 15, 2019 |
| Received | Aug 13, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192194
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.