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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K020271
Device Name LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
Applicant
Levitronix, LLC
85 First Ave.
Waltham,  MA  02451
Applicant Contact FARZAD PARSAIE
Correspondent
Levitronix, LLC
85 First Ave.
Waltham,  MA  02451
Correspondent Contact FARZAD PARSAIE
Regulation Number870.4360
Classification Product Code
KFM  
Date Received01/28/2002
Decision Date 03/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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