510(k) K130991 ยท EIH Powder, Porcelain
NEXXZR(TM)T AND NEXXZR(TM)S
| Applicant | Sagemax Bioceramics, Inc., Federal Way WA, US |
| Decision | Substantially Equivalent, Feb 10, 2014 |
| Received | Apr 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130991
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.