K-number	K100789
Device name	MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
Applicant	Evalve, Inc.
Product code	DRA
Device class	Class II
Decision date	Apr 21, 2010
Decision	Substantially Equivalent
Regulation	870.1280

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MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST

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