FDA 510(k) Application Details - K142221

Device Classification Name	Ring, Annuloplasty   More FDA Info for this Device
510(K) Number	K142221
Device Name	Ring, Annuloplasty
Applicant	SORIN GROUP ITALIA S.R.L VIA CRESCENTINO SN SALUGGIA 13040 IT Other 510(k) Applications for this Company
Contact	MAURO ERCOLANI 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	08/12/2014
Decision Date	08/29/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review