K-number	K191773
Device name	GORE BIO-A Tissue Reinforcement
Applicant	W. L. Gore & Associates, Inc.
Product code	OWT
Device class	Class II
Decision date	Jul 31, 2019
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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GORE BIO-A Tissue Reinforcement

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