510(k) K183009 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES
| Applicant | Hemostatix Medical Technologies, LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Nov 26, 2018 |
| Received | Oct 31, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183009
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.