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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 K160935
Device Name 8ch Foot Ankle Coil
Applicant
Shenzhen RF Tech Co., Ltd.
2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming
Shenzhen,  CN 518132
Applicant Contact Ke Xi
Correspondent
Shenzhen RF Tech Co., Ltd.
2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming
Shenzhen,  CN 518132
Correspondent Contact Ke Xi
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/04/2016
Decision Date 07/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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