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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suction Control, Intracardiac, Cardiopulmonary Bypass
510(k) Number K992657
Device Name IBC VRV, MODEL 1350
Applicant
International Biophysics Corp.
4020 S. Industrial Dr.
Suite 160
Austin,  TX  78744
Applicant Contact H. DAVID SHOCKLEY, JR.
Correspondent
International Biophysics Corp.
4020 S. Industrial Dr.
Suite 160
Austin,  TX  78744
Correspondent Contact H. DAVID SHOCKLEY, JR.
Regulation Number870.4430
Classification Product Code
DWD  
Date Received08/09/1999
Decision Date 02/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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