510(k) K111523 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
OSTEOCOOL (TM) RF ABLATION SYSTEM
| Applicant | Baylis Medical Co., Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Mar 13, 2012 |
| Received | Jun 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111523
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.