DISPOSABLE TPE INFUSION SET

Set, Administration, Intravascular

SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS

The following data is part of a premarket notification filed by Shan Dong Wei Gao Group Medical Polymer Products with the FDA for Disposable Tpe Infusion Set.

Pre-market Notification Details

Device IDK090459
510k NumberK090459
Device Name:DISPOSABLE TPE INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS STE.8D, ZHONGXIN ZHONGSHAN #2 ROADY ,NO.19, LANE 999, ZHONG Shan Nan Er Rd., Shanghai,  CN 200030
ContactDiana Hong
CorrespondentDiana Hong
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS STE.8D, ZHONGXIN ZHONGSHAN #2 ROADY ,NO.19, LANE 999, ZHONG Shan Nan Er Rd., Shanghai,  CN 200030
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-23
Decision Date2009-10-13
Summary:summary

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