K-number	K083316
Device name	3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
Applicant	Topcon Medical Systems, Inc.
Product code	OBO
Device class	Class II
Decision date	Mar 13, 2009
Decision	Substantially Equivalent
Regulation	886.1570

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View the full FDA submission: accessdata.fda.gov

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3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM

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