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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K121209
Device Name TERUMO PALL AL20X ARTERIAL FILTER
Applicant
Terumo Cardiovascular Systems Corporation
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact SUZANNE GRENIER
Correspondent
Terumo Cardiovascular Systems Corporation
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact SUZANNE GRENIER
Regulation Number870.4260
Classification Product Code
DTM  
Date Received04/20/2012
Decision Date 05/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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