PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB 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 Phmb Foam Dressing Non-adhesive, Phmb Foam Dressing Adhesive, Silicone Phmb Foam Dressing, Silicone Phmb Foam Dressing With Border.

Pre-market Notification Details

Device IDK192463
510k NumberK192463
Device Name:PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB 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 Received2019-09-09
Decision Date2020-05-14

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