510(k) K946165 ยท HRS Plate, Fixation, Bone
CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM
| Applicant | Elekta Instruments, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, May 23, 1995 |
| Received | Dec 19, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946165
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.