Name: Predicase
Price: 199 USD

K-number	K152524
Device name	Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
Applicant	Cook Incorporated
Product code	FGE
Device class	Class II
Decision date	Sep 30, 2015
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set

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