K-number	K153683
Device name	Trak Male Fertility Testing System
Applicant	Sandstone Diagnostics, Inc.
Product code	POV
Device class	Class II
Decision date	May 16, 2016
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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Trak Male Fertility Testing System

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