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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 K070213
Device Name PERFORMER CBP SYSTEM
Original Applicant
RAND S.R.L.
7611 northland drive
minneapolis,  MN  55428
Original Contact preeti jain
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received01/22/2007
Decision Date 03/21/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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