510(k) K013901 ยท GEX Powered Laser Surgical Instrument
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
| Applicant | Cardiofocus, Inc., Norton MA, US |
| Decision | Substantially Equivalent, Dec 20, 2001 |
| Received | Nov 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013901
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.