K-number	K171345
Device name	Cellvizio 100 Series Systems with Confocal Miniprobes
Applicant	Mauna Kea Technologies
Product code	OWN
Device class	Class II
Decision date	Aug 4, 2017
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 Systems with Confocal Miniprobes

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