510(k) K153564 ยท GEX Powered Laser Surgical Instrument
PURE CRYOGEN
| Applicant | Air Liquide Healthcare America Corporation, Houston TX, US |
| Decision | Substantially Equivalent, Mar 29, 2016 |
| Received | Dec 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153564
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.