BLOOD TRANSFUSION SET

Set, Blood Transfusion

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 Blood Transfusion Set.

Pre-market Notification Details

Device IDK083349
510k NumberK083349
Device Name:BLOOD TRANSFUSION SET
ClassificationSet, Blood Transfusion
Applicant SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS STE.8D, ZHONGXIN ZHONGSHAN MANSION,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 MANSION,NO.19, LANE 999, ZHONG Shan Nan Er Rd., Shanghai,  CN 200030
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-13
Decision Date2009-04-10
Summary:summary

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