510(k) K172987 ยท FYA Gown, Surgical
Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)
| Applicant | Gmax Industries, Inc., Hauppauge NY, US |
| Decision | Substantially Equivalent, Jul 13, 2018 |
| Received | Sep 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172987
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.