Safety Winged Blood Collection Sets

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 Safety Winged Blood Collection Sets.

Pre-market Notification Details

Device IDK211293
510k NumberK211293
Device Name:Safety Winged Blood Collection Sets
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Promisemed Hangzhou Meditech Co., Ltd. No. 12 Longtan Road, Cangqian Street Yuhang District Hangzhou City,  CN 311121
ContactZearou Yang
CorrespondentJohn Beasley
MedTech Review, LLC 257 Garnet Garden Street Henderson,  NV  89015
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-06-25

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