TK Sterile Piston Syringe Without Needle

Syringe, Piston

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 Sterile Piston Syringe Without Needle.

Pre-market Notification Details

Device IDK191642
510k NumberK191642
Device Name:TK Sterile Piston Syringe Without Needle
ClassificationSyringe, Piston
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 CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-19
Decision Date2020-01-06

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