Name: Predicase
Price: 199 USD

K-number	K061666
Device name	CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX
Applicant	Mauna Kea Technologies
Product code	GCJ
Device class	Class II
Decision date	Aug 24, 2006
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX

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