K-number	K082321
Device name	TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
Applicant	Terumo Cardiovascular Systems Corp.
Product code	KFM
Device class	Class II
Decision date	Feb 13, 2009
Decision	Substantially Equivalent
Regulation	870.4360

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View the full FDA submission: accessdata.fda.gov

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TERUMO ROCSAFE HYBRID PERFUSION SYSTEM

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