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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Pump Speed, Cardiopulmonary Bypass
510(k) Number K061369
Device Name TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
Applicant
CARDIAC ASSIST, INC.
240 ALPHA DR.
PITTSBURGH,  PA  15238
Applicant Contact ROBERT BOLLINGER
Correspondent
CARDIAC ASSIST, INC.
240 ALPHA DR.
PITTSBURGH,  PA  15238
Correspondent Contact ROBERT BOLLINGER
Regulation Number870.4380
Classification Product Code
DWA  
Date Received05/17/2006
Decision Date 08/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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