WEIGAO EMPTY CARTRIDGE SYRINGE

Syringe, Piston

SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.

The following data is part of a premarket notification filed by Shandong Weigao Group Medical Polymer Co.,ltd. with the FDA for Weigao Empty Cartridge Syringe.

Pre-market Notification Details

Device IDK081241
510k NumberK081241
Device Name:WEIGAO EMPTY CARTRIDGE SYRINGE
ClassificationSyringe, Piston
Applicant SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai,  CN 200030
ContactDiana Hong
CorrespondentDiana Hong
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai,  CN 200030
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-01
Decision Date2008-09-08
Summary:summary

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