Name: Predicase
Price: 199 USD

K-number	K010936
Device name	MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Applicant	W. L. Gore & Associates, Inc.
Product code	OXD
Device class	Class II
Decision date	May 21, 2001
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

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