510(k) K925077 ยท FYC Gown, Isolation, Surgical
POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS
| Applicant | Medtek Development Corp., Bloomington IL, US |
| Decision | Substantially Equivalent, Aug 16, 1993 |
| Received | Oct 7, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925077
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.