FDA 510(k) Application Details - K980534

Device Classification Name	Ring, Annuloplasty   More FDA Info for this Device
510(K) Number	K980534
Device Name	Ring, Annuloplasty
Applicant	THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG 18011 SOUTH MITCHELL IRVINE, CA 92714 US Other 510(k) Applications for this Company
Contact	JEAN CHAMPION 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	02/11/1998
Decision Date	04/30/1998
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