Disposable Insulin Pen Needle

Needle, Hypodermic, Single Lumen

Ningbo Medsun Medical Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Medsun Medical Co., Ltd. with the FDA for Disposable Insulin Pen Needle.

Pre-market Notification Details

Device IDK221178
510k NumberK221178
Device Name:Disposable Insulin Pen Needle
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Ningbo Medsun Medical Co., Ltd. No.55 Jinxi Road, Zhenhai Ningbo,  CN 315221
ContactLiu Ping
CorrespondentMarvin Li
Shanghai Mihe Enterprise Management Consulting Co., Ltd. Room 313, No. 620 Zhennan Road (Building 9, Tongji University Science Park), Putuo District Shanghai,  CN 200331
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-25
Decision Date2022-11-17

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