FDA 510(k) Application Details - K963756

Device Classification Name	Sucker, Cardiotomy Return, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K963756
Device Name	Sucker, Cardiotomy Return, 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 SHOCKLEY, JR. Other 510(k) Applications for this Contact
Regulation Number	870.4420   More FDA Info for this Regulation Number
Classification Product Code	DTS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/1996
Decision Date	11/14/1997
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