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.
|Device Name:||PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing With Border|
|Classification||Dressing, Wound, Drug|
|Applicant||Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, CN 518109|
Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, CN 518109
|CFR Regulation Number||510(k) Premarket Notification [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|