FDA 510(k) Application Details - K992785

Device Classification Name	Cpb Check Valve, Retrograde Flow, In-Line   More FDA Info for this Device
510(K) Number	K992785
Device Name	Cpb Check Valve, Retrograde Flow, In-Line
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	870.4400   More FDA Info for this Regulation Number
Classification Product Code	MJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/1999
Decision Date	01/14/2000
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