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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 K242126
Device Name I.V. Administration Set
Applicant
Bq Plus Medical Co., Ltd.
# 18, Cheye Rd., Chedun Town
Shanghai,  CN 201611
Applicant Contact Jin Zhang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg.,
1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/19/2024
Decision Date 08/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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