FDA 510(k) Application Details - K960923

Device Classification Name	Rotator, Prosthetic Heart Valve   More FDA Info for this Device
510(K) Number	K960923
Device Name	Rotator, Prosthetic Heart Valve
Applicant	CARBOMEDICS, INC. 1300-C EAST ANDERSON LN. AUSTIN, TX 78752 US Other 510(k) Applications for this Company
Contact	DAVID M MAKANANI 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	03/06/1996
Decision Date	04/29/1996
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