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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name closed antineoplastic and hazardous drug reconstitution and transfer system
510(k) Number K201460
Device Name Closed System Transfer Device
Applicant
Shinva Ande Healthcare Apparatus Co., Ltd.
No.77 Development Zone North Road, New & Hi-Tech Zone
Zibo,  CN 255086
Applicant Contact XiaoLei Tian
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.5440
Classification Product Code
ONB  
Date Received06/02/2020
Decision Date 11/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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