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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
510(k) Number K963698
Device Name CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 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 Number870.4410
Classification Product Code
DTY  
Date Received09/16/1996
Decision Date 03/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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