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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 K200836
Device Name 8ch Flex Suite
Applicant
Shenzhen RF Tech Co., Ltd.
2-F,Bld4 Juhui Industrial Park, Tianliao,Guangming
Shenzhen,  CN 518132
Applicant Contact Gary Wang
Correspondent
Shenzhen RF Tech Co., Ltd.
2-F,Bld4 Juhui Industrial Park, Tianliao,Guangming
Shenzhen,  CN 518132
Correspondent Contact Gary Wang
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/31/2020
Decision Date 07/22/2020
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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