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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, stationary
510(k) Number K121854
Device Name SYSTEM, X-RAY, STATIONARY
Original Applicant
BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO.
p.o. box 237-023
shanghai,  CN 200237
Original Contact diana hong
Regulation Number892.1680
Classification Product Code
KPR  
Date Received06/25/2012
Decision Date 08/22/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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