K-number	K004023
Device name	INTRA OPERATIVE RADIATION THERAPY
Applicant	Arplay Medical S.A.
Product code	IYE
Device class	Class II
Decision date	Sep 21, 2001
Decision	Substantially Equivalent
Regulation	892.5050

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View the full FDA submission: accessdata.fda.gov

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INTRA OPERATIVE RADIATION THERAPY

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