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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 K223225
Device Name 8ch T/R Knee Coil
Applicant
Shenzhen Rf Tech Co., Ltd.
2-F,Bld4 Juhui Industrial Park, Tianliao,Guangming
Shenzhen,  CN 518132
Applicant Contact Gary Wang
Correspondent
Bonnier Quality Supervision Consulting (Jm) Center
Hailunxinyuan #3203, Jianghai District
Jiangmen,  CN 529000
Correspondent Contact Gary Wang
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/18/2022
Decision Date 02/14/2023
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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