510(k) K945371 ยท FYA Gown, Surgical
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS
| Applicant | Standard Textile Co., Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Apr 27, 1995 |
| Received | Nov 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945371
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.