K-number	K111047
Device name	CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
Applicant	Mauna Kea Technologies, Inc.
Product code	OWN
Device class	Class II
Decision date	Aug 8, 2011
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

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