510(k) K082391 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PRIMAEVA MEDICAL RENESIS SYSTEM
| Applicant | Primaeva Medical, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Sep 1, 2009 |
| Received | Aug 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082391
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.