K-number	K980016
Device name	MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
Applicant	Genzyme Surgical Product (Genzyme Biosurgery)
Product code	MOP
Device class	Class I
Decision date	Aug 7, 1998
Decision	Substantially Equivalent
Regulation	870.3935

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View the full FDA submission: accessdata.fda.gov

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MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE

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