Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border

Dressing, Wound, Drug

Winner Medical Co., Ltd.

The following data is part of a premarket notification filed by Winner Medical Co., Ltd. with the FDA for Ag Foam Dressing Non-adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border.

Pre-market Notification Details

Device IDK191819
510k NumberK191819
Device Name:Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border
ClassificationDressing, Wound, Drug
Applicant Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen,  CN 518109
ContactDan Wang
CorrespondentDan Wang
Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen,  CN 518109
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-07-05
Decision Date2020-05-14

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.