K-number	DEN160005
Device name	Hem-Avert Perianal Stabilizer
Applicant	Stetrix, Inc.
Product code	PNU
Device class	Class II
Decision date	Dec 19, 2016
Decision	Not Substantially Equivalent
Regulation	884.5210

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View the full FDA submission: accessdata.fda.gov

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Hem-Avert Perianal Stabilizer

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