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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Sonometer
510(k) Number K123238
Device Name ACHILLES
Applicant
Ge Medical Systems China Co., Ltd.
# 19 Changjiang Rd.
National Hi-Tech Dev. Zone
Wuxi, Jiangsu Province,  CN 214028
Applicant Contact LIU ZHAO
Correspondent
Ge Medical Systems China Co., Ltd.
# 19 Changjiang Rd.
National Hi-Tech Dev. Zone
Wuxi, Jiangsu Province,  CN 214028
Correspondent Contact LIU ZHAO
Regulation Number892.1180
Classification Product Code
MUA  
Subsequent Product Code
LLZ  
Date Received10/16/2012
Decision Date 02/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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