FDA 510(k) Application Details - K101212

Device Classification Name	Ring, Annuloplasty   More FDA Info for this Device
510(K) Number	K101212
Device Name	Ring, Annuloplasty
Applicant	MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	BECKY HANNACK Other 510(k) Applications for this Contact
Regulation Number	870.3800   More FDA Info for this Regulation Number
Classification Product Code	KRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2010
Decision Date	08/07/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review