510(k) K100078 ยท GEX Powered Laser Surgical Instrument
MODIFIED STRAIGHT FIRE LASER FIBER
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Feb 12, 2010 |
| Received | Jan 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100078
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.