510(k) K093855 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HALO 360 & SIZING BALLOON, MODEL 3441C
| Applicant | Barrx Medical, Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 15, 2010 |
| Received | Dec 16, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093855
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.