510(k) K973789 ยท GXP Methyl Methacrylate For Cranioplasty
NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
| Applicant | Norian Corp., Cupertino CA, US |
| Decision | Substantially Equivalent, May 18, 1998 |
| Received | Oct 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973789
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.