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FDA 510(k) Application Details - K131817
Device Classification Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
More FDA Info for this Device
510(K) Number
K131817
Device Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD.
NO. 982 COGYUN ROAD
BAIYUN DISTRICT
GUANGZHOU, GUANGDONG 510420 CN
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Contact
MIKE GU
Other 510(k) Applications for this Contact
Regulation Number
876.5990
More FDA Info for this Regulation Number
Classification Product Code
LNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/20/2013
Decision Date
09/26/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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