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FDA 510(k), K131817, EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
FDA 510(k), K131817, EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
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510(K) Number: K131817
Device Name: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Manufacturer: OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD.
Device Classification Name: Lithotriptor, Extracorporeal Shock-Wave, Urological
Regulation Number: 876.5990
Classification Product Code: LNS
Date Received: 06/20/2013
Decision Date: 09/26/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Manufacturer: OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD.
Device Classification Name: Lithotriptor, Extracorporeal Shock-Wave, Urological
Regulation Number: 876.5990
Classification Product Code: LNS
Date Received: 06/20/2013
Decision Date: 09/26/2014
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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