Insulin Syringes Without Needle

Syringe, Piston

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 Insulin Syringes Without Needle.

Pre-market Notification Details

Device IDK221045
510k NumberK221045
Device Name:Insulin Syringes Without Needle
ClassificationSyringe, Piston
Applicant Berpu Medical Technology Co., Ltd No. 14 Xingji Road, Yongxing Street, Longwan District Wenzhou,  CN 325000
ContactBuxin Yu
CorrespondentBuxin Yu
Berpu Medical Technology Co., Ltd No. 14 Xingji Road, Yongxing Street, Longwan District Wenzhou,  CN 325000
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-08
Decision Date2022-11-03

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