510(k) K131817 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
| Applicant | Osmunda Medical Device Consulting Co., Ltd., Guangzhou, Guangdong, CN |
| Decision | Substantially Equivalent, Sep 26, 2014 |
| Received | Jun 20, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131817
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.