K-number	K122603
Device name	ONTEX AND OTHER PROPRIETARY NAMES
Applicant	Ontex Bvba
Product code	HEB
Device class	Class II
Decision date	Dec 19, 2012
Decision	Substantially Equivalent
Regulation	884.5470

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Source

View the full FDA submission: accessdata.fda.gov

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ONTEX AND OTHER PROPRIETARY NAMES

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