K-number	K081281
Device name	OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
Applicant	Nucletron Corporation
Product code	MUJ
Device class	Class II
Decision date	May 20, 2008
Decision	Substantially Equivalent
Regulation	892.5050

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View the full FDA submission: accessdata.fda.gov

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OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)

Everything you need for a 510(k) submission. Nothing you don't.