FDA 510(k) Application Details - K970375

Device Classification Name	Ring, Annuloplasty   More FDA Info for this Device
510(K) Number	K970375
Device Name	Ring, Annuloplasty
Applicant	CARBOMEDICS, INC. 1300 EAST ANDERSON LN. AUSTIN, TX 78752-1793 US Other 510(k) Applications for this Company
Contact	MICHAEL C MORTON 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	02/03/1997
Decision Date	07/25/1997
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