510(k) K043004 ยท FYA Gown, Surgical
STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
| Applicant | Viasys Medsystems, Wheeling IL, US |
| Decision | Substantially Equivalent, Mar 16, 2005 |
| Received | Nov 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043004
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.