Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

Needle, Hypodermic, Single Lumen

Tianjin Huahong Technology Co., Ltd.

The following data is part of a premarket notification filed by Tianjin Huahong Technology Co., Ltd. with the FDA for Insulin Pen Needle (ordinary Type), Insulin Pen Needle (safety Type).

Pre-market Notification Details

Device IDK202319
510k NumberK202319
Device Name:Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone Tianjin,  CN 300308
ContactYan Li
CorrespondentYan Li
Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone Tianjin,  CN 300308
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-17
Decision Date2021-11-12

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