510(k) K152702 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)
| Applicant | Ent Biotech Solutions, Gross Pointe Farms MI, US |
| Decision | Substantially Equivalent, Feb 18, 2016 |
| Received | Sep 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152702
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.