Name: Predicase
Price: 199 USD

K-number	K151386
Device name	C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
Applicant	Atrium Medical Corporation
Product code	FTL
Device class	Class II
Decision date	Oct 22, 2015
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic

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