K-number	K160612
Device name	Sumitomo Proton Therapy System
Applicant	Sumitomo Heavy Industries, Ltd.
Product code	LHN
Device class	Class II
Decision date	Aug 17, 2016
Decision	Substantially Equivalent
Regulation	892.5050

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View the full FDA submission: accessdata.fda.gov

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Sumitomo Proton Therapy System

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