TK Insulin Syringe With/without Saftey Retractable Device

Syringe, Antistick

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 Insulin Syringe With/without Saftey Retractable Device.

Pre-market Notification Details

Device IDK191639
510k NumberK191639
Device Name:TK Insulin Syringe With/without Saftey Retractable Device
ClassificationSyringe, Antistick
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 CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-19
Decision Date2020-09-11

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.