Name: Predicase
Price: 199 USD

K-number	K160229
Device name	Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
Applicant	Cook Ireland, Ltd.
Product code	FCG
Device class	Class II
Decision date	Mar 21, 2016
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle

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