510(k) K010799 ยท FYA Gown, Surgical
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
| Applicant | Standard Textile Co., Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jun 7, 2001 |
| Received | Mar 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010799
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.