K-number	K011395
Device name	MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
Applicant	Medtronic Vascular
Product code	KRH
Device class	Class II
Decision date	Jul 12, 2001
Decision	Substantially Equivalent
Regulation	870.3800

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View the full FDA submission: accessdata.fda.gov

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MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B

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