DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT

Injector And Syringe, Angiographic

SHANDONG WEIGAO MEDICAL POLYMER CO., LTD

The following data is part of a premarket notification filed by Shandong Weigao Medical Polymer Co., Ltd with the FDA for Disposable Angiographic Syringe, Model(s) Ct-200-ne, Ct-200-ma, Ct-200+200-ma, Ct-200-lf, Ct -100-ne, Ct-200ne, Ct-50+ct.

Pre-market Notification Details

Device IDK082439
510k NumberK082439
Device Name:DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT
ClassificationInjector And Syringe, Angiographic
Applicant SHANDONG WEIGAO MEDICAL POLYMER CO., LTD SUITE 8D, NO.19, LANE 999, ZHONGSHAN NO.2 ROAD(S) Shanghai,  CN 200030
ContactDiana Hong
CorrespondentDiana Hong
SHANDONG WEIGAO MEDICAL POLYMER CO., LTD SUITE 8D, NO.19, LANE 999, ZHONGSHAN NO.2 ROAD(S) Shanghai,  CN 200030
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-25
Decision Date2009-03-23
Summary:summary

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