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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K822068
Device Name GAMBRO PUMP CONSOLE CSL
Original Applicant
GAMBRO, INC.
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received07/14/1982
Decision Date 08/24/1982
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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