K-number	K173333
Device name	GORE ENFORM Biomaterial
Applicant	W. L. Gore & Associates, Inc.
Product code	OXF
Device class	Class II
Decision date	Apr 5, 2018
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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GORE ENFORM Biomaterial

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