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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 K112002
Device Name CAROTID COIL
Applicant
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
BLDG 8, LANE 1199, JIDI ROAD
SHANGHAI,  CN 201107
Applicant Contact MEIJUAN CHEN
Correspondent
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
BLDG 8, LANE 1199, JIDI ROAD
SHANGHAI,  CN 201107
Correspondent Contact MEIJUAN CHEN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/13/2011
Decision Date 11/18/2011
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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