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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K071847
Device Name MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL
Original Applicant
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
6a, building-2, no. 398
tianlin rd
shanghai,  CN 200233
Original Contact songtao zhang
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/05/2007
Decision Date 07/23/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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