TK Intravascular Administration Set

Set, Administration, Intravascular

Anhui Tiankang Medical Technology Co.,Ltd.

The following data is part of a premarket notification filed by Anhui Tiankang Medical Technology Co.,ltd. with the FDA for Tk Intravascular Administration Set.

Pre-market Notification Details

Device IDK191640
510k NumberK191640
Device Name:TK Intravascular Administration Set
ClassificationSet, Administration, Intravascular
Applicant Anhui Tiankang Medical Technology Co.,Ltd. No.228 Weiyi Road, Economic Development Zone Tianchang,  CN 239300
ContactBai Baodong
CorrespondentBai Baodong
Anhui Tiankang Medical Technology Co.,Ltd. No.228 Weiyi Road, Economic Development Zone Tianchang,  CN 239300
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-19
Decision Date2020-08-26

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