FDA 510(k) Application Details - K962154

Device Classification Name	Holder, Heart-Valve, Prosthesis   More FDA Info for this Device
510(K) Number	K962154
Device Name	Holder, Heart-Valve, Prosthesis
Applicant	CARBOMEDICS, INC. 1300 EAST ANDERSON LN. AUSTIN, TX 78752-1793 US Other 510(k) Applications for this Company
Contact	JOY FISHER-SHUGART Other 510(k) Applications for this Contact
Regulation Number	870.3935   More FDA Info for this Regulation Number
Classification Product Code	DTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/1996
Decision Date	08/27/1996
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