K-number	K120730
Device name	LOUTREX TOPICAL CREAM
Applicant	Acella Pharmaceuticals, LLC
Product code	FRO
Device class	Class U
Decision date	Sep 6, 2012
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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LOUTREX TOPICAL CREAM

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