510(k) K913191 ยท GEX Powered Laser Surgical Instrument
DORNIER LASER LITHOTRIPTER IMPACT
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Oct 16, 1991 |
| Received | Jul 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913191
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.