FDA 510(k) Application Details - K974648

Device Classification Name	Rotator, Prosthetic Heart Valve   More FDA Info for this Device
510(K) Number	K974648
Device Name	Rotator, Prosthetic Heart Valve
Applicant	SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. AUSTIN, TX 78752-1793 US Other 510(k) Applications for this Company
Contact	EDWARD E NEWTON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MOP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/1997
Decision Date	08/04/1998
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