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FDA 510(k) Application Details - K221406
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K221406
Device Name
Set, I.V. Fluid Transfer
Applicant
Jiangsu Caina Medical Co., Ltd.
No.23, Huanxi Road, Zhutang Town
Jiangyin 214415 CN
Other 510(k) Applications for this Company
Contact
Jianwei Pan
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
LHI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/16/2022
Decision Date
10/28/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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