Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached 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 Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle.

Pre-market Notification Details

Device IDK213158
510k NumberK213158
Device Name:Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle
ClassificationSyringe, Piston
Applicant Berpu Medical Technology Co., Ltd. No. 14 Xingji Road, Yongxing Street, Wenzhou,  CN 325000
ContactDavid Yu
CorrespondentDavid Yu
Berpu Medical Technology Co., Ltd. No. 14 Xingji Road, Yongxing Street, Wenzhou,  CN 325000
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-28
Decision Date2022-07-21

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