FDA 510(k) K131817, EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, by Osmunda Medical Device Consulting Co., Ltd.
FDA 510(k) K131817, EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, by Osmunda Medical Device Consulting Co., Ltd.
Device Classification Name: Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number: K131817
Device Name: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Applicant: Osmunda Medical Device Consulting Co., Ltd.
Regulation Number: 876.599
Classification Product Code: LNS
Date Received: 06/20/2013
Decision Date: 09/26/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 1,489
Fully redacted pages: 1,053
Content pages: 436
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