K-number	K190819
Device name	Silicone PHMB Foam Wound Dressing
Applicant	Advanced Medical Solutions, Ltd.
Product code	FRO
Device class	Class U
Decision date	Jul 25, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Silicone PHMB Foam Wound Dressing

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