510(k) K112505 ยท GEX Powered Laser Surgical Instrument
ETHEREA
| Applicant | Regulatory Insight, Inc., Greenwood Village CO, US |
| Decision | Substantially Equivalent, Apr 6, 2012 |
| Received | Aug 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112505
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.