510(k) K964760 ยท GEX Powered Laser Surgical Instrument
DORNIER MEDILAS FIBER TOME LASER
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Feb 19, 1997 |
| Received | Nov 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964760
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.