K-number	K965137
Device name	FOGARTY VALVULOTOME MODEL 700091
Applicant	Baxter Edwards
Product code	MGZ
Device class	Class II
Decision date	Jun 4, 1997
Decision	Substantially Equivalent
Regulation	870.4885

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View the full FDA submission: accessdata.fda.gov

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FOGARTY VALVULOTOME MODEL 700091

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