K-number	K042175
Device name	HEPARINASE HR ACT CONTROL, MODEL 550-12
Applicant	Medtronic Vascular
Product code	GGN
Device class	Class II
Decision date	Oct 18, 2004
Decision	Substantially Equivalent
Regulation	864.5425

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View the full FDA submission: accessdata.fda.gov

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HEPARINASE HR ACT CONTROL, MODEL 550-12

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