Name: Predicase
Price: 199 USD

K-number	K150891
Device name	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
Applicant	Covidien, LLC( Formerly Beacon Endoscopic Corp.)
Product code	FCG
Device class	Class II
Decision date	May 1, 2015
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System

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