FDA 510(k) Application Details - K961246

Device Classification Name	Ring, Annuloplasty   More FDA Info for this Device
510(K) Number	K961246
Device Name	Ring, Annuloplasty
Applicant	ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA ST. PAUL, MN 55117 US Other 510(k) Applications for this Company
Contact	JONAS RUNQUIST 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	04/01/1996
Decision Date	02/14/1997
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review