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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00616784890524 K191639 000
10812460024789 K191639 000
10812460026240 K191639 000
10812460026271 K191639 000
10812460026295 K191639 000
M99208012905S5 K191639 000
00616784890128 K191639 000
00616784890227 K191639 000
00616784890326 K191639 000
00616784890425 K191639 000
10812460024772 K191639 000

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