510(k) K130344 ยท GEX Powered Laser Surgical Instrument
DORNIER MEDILAS UROPULSE
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Mar 21, 2013 |
| Received | Feb 11, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130344
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.