K-number	K181646
Device name	Celesteion, PCA-9000A/3, V6.5
Applicant	Canon Medical Systems Corporation
Product code	JAK
Device class	Class II
Decision date	Nov 16, 2018
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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Celesteion, PCA-9000A/3, V6.5

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