510(k) K080406 ยท GEX Powered Laser Surgical Instrument
IPULSE, MODEL I400
| Applicant | Cyden Limited, Swansea, Wales, GB |
| Decision | Substantially Equivalent, Mar 10, 2008 |
| Received | Feb 14, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080406
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.