TM SAFETY NEEDLE

Needle, Hypodermic, Single Lumen

ThinkMed Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Thinkmed Medical Technology Co., Ltd. with the FDA for Tm Safety Needle.

Pre-market Notification Details

Device IDK142765
510k NumberK142765
Device Name:TM SAFETY NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant ThinkMed Medical Technology Co., Ltd. No.4 Building, 322 Hongyang Road, Qiandeng Town Kunshan,  CN 215341
ContactGarfield Wang
CorrespondentGarfield Wang
ThinkMed Medical Technology Co., Ltd. No.4 Building, 322 Hongyang Road, Qiandeng Town Kunshan,  CN 215341
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-25
Decision Date2015-08-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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