FDA 510(k) Application Details - K992964

Device Classification Name	Valve, Pressure Relief, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K992964
Device Name	Valve, Pressure Relief, Cardiopulmonary Bypass
Applicant	INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 AUSTIN, TX 78744 US Other 510(k) Applications for this Company
Contact	H. DAVID SHOCKLET, JR Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MNJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/1999
Decision Date	11/19/1999
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