WUZHOU SYRINGE, WITH/WITHOUT NEEDLE

Syringe, Piston

WENZHOU WUZHOU GROUP CO. LTD.

The following data is part of a premarket notification filed by Wenzhou Wuzhou Group Co. Ltd. with the FDA for Wuzhou Syringe, With/without Needle.

Pre-market Notification Details

Device IDK060211
510k NumberK060211
Device Name:WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
ClassificationSyringe, Piston
Applicant WENZHOU WUZHOU GROUP CO. LTD. 1800 CENTURY PARK EAST SUITE 600 Los Angeles,  CA  90067
ContactGeorge Su
CorrespondentLaura Danielson
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-01-27
Decision Date2006-02-10
Summary:summary

NIH GUDID Devices

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