TK Safety Needle

Needle, Hypodermic, Single Lumen

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 Safety Needle.

Pre-market Notification Details

Device IDK191644
510k NumberK191644
Device Name:TK Safety Needle
ClassificationNeedle, Hypodermic, Single Lumen
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 CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-19
Decision Date2020-08-06

NIH GUDID Devices

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