Dual-Safety Pen Needle

Needle, Hypodermic, Single Lumen

Promisemed Hangzhou Meditech Co., Ltd.

The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Dual-safety Pen Needle.

Pre-market Notification Details

Device IDK191853
510k NumberK191853
Device Name:Dual-Safety Pen Needle
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Promisemed Hangzhou Meditech Co., Ltd. Bldg. 1, No. 12, Longtan Road, Cangqian Street Yuhang District Hangzhou City,  CN
ContactZearou Yang
CorrespondentJohn Beasley
MedTech Review, LLC 257 Garnet Garden Street Henderson,  NV  98015
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-10
Decision Date2019-09-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00015482273835 K191853 000
00015482273538 K191853 000
10015482272835 K191853 000
10015482272538 K191853 000

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