ENTERAL FEEDING BAG AND SETS

Tubes, Gastrointestinal (and Accessories)

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 Enteral Feeding Bag And Sets.

Pre-market Notification Details

Device IDK102741
510k NumberK102741
Device Name:ENTERAL FEEDING BAG AND SETS
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. P.O. BOX 237-023 Shanghai,  CN 200030
ContactDiana Hong
CorrespondentDiana Hong
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. P.O. BOX 237-023 Shanghai,  CN 200030
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-22
Decision Date2011-11-08
Summary:summary

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