510(k) K921549 ยท GEX Powered Laser Surgical Instrument
DORNIER FIBERTOME 100 WATT SURGICAL LASER
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Feb 18, 1993 |
| Received | Apr 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921549
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.