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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 K092962
Device Name CAROTID COIL 5000004901
Applicant
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
BLDG 8, LANE 1199, JIDI ROAD
SHANGHAI,  CN 201107
Applicant Contact JIE HUANG
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/25/2009
Decision Date 10/09/2009
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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