K-number	K130426
Device name	SUMITOMO PROTON THERAPY SYSTEM
Applicant	Sumitomo Heavy Industries, Ltd.
Product code	LHN
Device class	Class II
Decision date	Nov 19, 2013
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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SUMITOMO PROTON THERAPY SYSTEM

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