Name: Predicase
Price: 199 USD

K-number	K163264
Device name	Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled
Applicant	Avinger, Inc.
Product code	MCW
Device class	Class II
Decision date	Dec 21, 2016
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled

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