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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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.
# 982 Cogyun Rd.
Baiyun District
Guangzhou, Guangdong,  CN 510420
Applicant Contact MIKE GU
Correspondent
Osmunda Medical Device Consulting Co., Ltd.
# 982 Cogyun Rd.
Baiyun District
Guangzhou, Guangdong,  CN 510420
Correspondent Contact MIKE GU
Regulation Number876.5990
Classification Product Code
LNS  
Date Received06/20/2013
Decision Date 09/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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