Name: Predicase
Price: 199 USD

K-number	K112945
Device name	ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
Applicant	Inrad, Inc.
Product code	KNW
Device class	Class II
Decision date	Nov 3, 2011
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM

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