Antibacterial Bandage

Dressing, Wound, Drug

Jiangsu Excellence Medical Supplies Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Excellence Medical Supplies Co., Ltd with the FDA for Antibacterial Bandage.

Pre-market Notification Details

Device IDK201324
510k NumberK201324
Device Name:Antibacterial Bandage
ClassificationDressing, Wound, Drug
Applicant Jiangsu Excellence Medical Supplies Co., Ltd No.65 Huiling West Road, Zouqu Town, Zhonglou District Changzhou,  CN 203144
ContactYanhua Li
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2020-05-18
Decision Date2021-02-05

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