510(k) K140006 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ENDOSHIELD BURN PROTECTION SYSTEM
| Applicant | Encision, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Jun 16, 2014 |
| Received | Jan 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140006
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.