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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K955380
Device Name IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
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 Number870.4330
Classification Product Code
DRY  
Date Received11/24/1995
Decision Date 05/14/1996
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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