510(k) K110897 ยท GEX Powered Laser Surgical Instrument
CORTEX CO2 / ER:YAG LASER SYSTEM
| Applicant | Sandstone Medical Technologies, LLC, Birmingham AL, US |
| Decision | Substantially Equivalent, Jul 1, 2011 |
| Received | Mar 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110897
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.