510(k) K952363 ยท ELA Instrument, Hand, Calculus Removal
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Aug 15, 1995 |
| Received | May 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952363
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.