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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
Applicant
RAND S.R.L.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Applicant Contact PREETI JAIN
Correspondent
RAND S.R.L.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Correspondent Contact PREETI JAIN
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received01/22/2007
Decision Date 03/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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