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FDA 510(k) Application Details - K230756
Device Classification Name
Saline, Vascular Access Flush
More FDA Info for this Device
510(K) Number
K230756
Device Name
Saline, Vascular Access Flush
Applicant
Anhui Tiankang Medical Technology Co., Ltd.
No. 228 Weiyi Road, Economic Development Zone
Tianchang CN
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Contact
Bai Baodong
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
NGT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/20/2023
Decision Date
08/12/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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