510(k) K041540 ยท FYA Gown, Surgical
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
| Applicant | Standard Textile Co., Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, May 5, 2005 |
| Received | Jun 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041540
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.