K-number	K170911
Device name	NEOCERA Advanced Barrier Cream
Applicant	Exeltis USA Dermatology, LLC
Product code	FRO
Device class	Class U
Decision date	Aug 22, 2017
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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NEOCERA Advanced Barrier Cream

Everything you need for a 510(k) submission. Nothing you don't.