510(k) K091097 ยท FYA Gown, Surgical
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
| Applicant | Promedical Products Co., Ltd., Depew NY, US |
| Decision | Substantially Equivalent, May 27, 2009 |
| Received | Apr 16, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091097
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.