510(k) K080093 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, May 2, 2008 |
| Received | Jan 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080093
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.