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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sucker, cardiotomy return, cardiopulmonary bypass
510(k) Number K963756
Device Name IBC CARDIAC SUCTION WARD
Applicant
INTERNATIONAL BIOPHYSICS CORP.
4020 SOUTH INDUSTRIAL DR.
SUITE 160
AUSTIN,  TX  78744
Applicant Contact H. DAVID SHOCKLEY, JR.
Correspondent
INTERNATIONAL BIOPHYSICS CORP.
4020 SOUTH INDUSTRIAL DR.
SUITE 160
AUSTIN,  TX  78744
Correspondent Contact H. DAVID SHOCKLEY, JR.
Regulation Number870.4420
Classification Product Code
DTS  
Date Received09/17/1996
Decision Date 11/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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