Safety Pen Needle For Single Use, Insulin Pen Needles

Needle, Hypodermic, Single Lumen

Berpu Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Berpu Medical Technology Co., Ltd. with the FDA for Safety Pen Needle For Single Use, Insulin Pen Needles.

Pre-market Notification Details

Device IDK212514
510k NumberK212514
Device Name:Safety Pen Needle For Single Use, Insulin Pen Needles
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Berpu Medical Technology Co., Ltd. NO.14 Xingji Road,Yongxing Street, Longwan District Wenzhou,  CN 325000
ContactBuxin Yu
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-10
Decision Date2022-04-29

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