510(k) K983009 ยท GXP Methyl Methacrylate For Cranioplasty
BSM- BONE SUBSTITUTE MATERIAL
| Applicant | Etex Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Nov 25, 1998 |
| Received | Aug 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983009
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.