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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Temperature, Cardiopulmonary Bypass
510(k) Number K874927
Device Name PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
Applicant
Pioneering Technologies, Inc.
C/O Buckman Company, Inc.
921 Calle Verde
Martinez,  CA  94553
Applicant Contact DAVID W SCHLERG
Correspondent
Pioneering Technologies, Inc.
C/O Buckman Company, Inc.
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact DAVID W SCHLERG
Regulation Number870.4250
Classification Product Code
DWC  
Date Received12/02/1987
Decision Date 01/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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