510(k) K161446 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Biopor Porous Polyethylene Implants
| Applicant | Ceremed , Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Sep 27, 2016 |
| Received | May 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161446
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.