510(k) K173779 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
REXMONO, PDREX
| Applicant | Sm Eng Co., Ltd., Sasang-Gu, KR |
| Decision | Substantially Equivalent, Mar 12, 2018 |
| Received | Dec 12, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173779
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.