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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K153295
Device Name TandemLung Oxygenator
Applicant
CARDIAC ASSIST, INC.
240 ALPHA DR.
PITTSBURGH,  PA  15238
Applicant Contact GREG JOHNSON
Correspondent
CARDIAC ASSIST, INC.
240 ALPHA DR.
PITTSBURGH,  PA  15238
Correspondent Contact GREG JOHNSON
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received11/13/2015
Decision Date 02/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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