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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K210381
Device Name I.V. Administration Set
Applicant
Bq Plus Medical Co., Ltd.
# 18, Cheye Rd., Chedun Town, Songjiang
Shanghai,  CN 201611
Applicant Contact Jin Zhang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/09/2021
Decision Date 08/14/2021
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
Predetermined Change
Control Plan Authorized		 No
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