510(k) K012240 ยท FYA Gown, Surgical
MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
| Applicant | Mercan AB, Austin TX, US |
| Decision | Substantially Equivalent, Oct 15, 2001 |
| Received | Jul 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012240
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.