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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 K151653
Device Name 8ch Foot Ankle Coil
Applicant
SHENZHEN RFTECH CO., LTD.
2-F, BLDG 4, JUHUI INDUSTRIAL PARK, TIANLIAO, GUANGMING,
SHENZHEN,  CN 51832
Applicant Contact KE XI
Correspondent
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD
7TH FLOOR, JINGUI BUSINESS BUILDING, NO. 982 CONGYUN RD.,
BAIYUN DISTRICT
GUANGZHOU,  CN 510420
Correspondent Contact MIKE GU
Regulation Number892.1000
Classification Product Code
MOS  
Date Received06/18/2015
Decision Date 08/07/2015
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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