Name: Predicase
Price: 199 USD

K-number	K183640
Device name	Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
Applicant	Mauna Kea Technologies
Product code	OWN
Device class	Class II
Decision date	Feb 22, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes

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