510(k) K082911 ยท GEX Powered Laser Surgical Instrument
SMOOTHCOOL HR SYSTEM
| Applicant | Jeisys Medical, Inc., Greenwood Village CO, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Sep 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082911
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.