510(k) K151262 ยท ELW Material, Impression
Hyflex Heavy, Hyflex Mono, Hyflex Light
| Applicant | Osstem Implant Co., Ltd., Busan, KR |
| Decision | Substantially Equivalent, Sep 21, 2015 |
| Received | May 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151262
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.