Name: Predicase
Price: 199 USD

K-number	K070644
Device name	GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
Applicant	W. L. Gore & Associates, Inc.
Product code	FTL
Device class	Class II
Decision date	Apr 2, 2007
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS

Everything you need for a 510(k) submission. Nothing you don't.