FDA 510(k) Application Details - K992056

Device Classification Name	Ring, Annuloplasty   More FDA Info for this Device
510(K) Number	K992056
Device Name	Ring, Annuloplasty
Applicant	SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. AUSTIN, TX 78752 US Other 510(k) Applications for this Company
Contact	ROBERT M WOLFARTH 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	06/18/1999
Decision Date	10/12/1999
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