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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 K083747
Device Name TERUMO PALL AL3X ARTERIAL FILTER
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact GARRY A COURTNEY
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact GARRY A COURTNEY
Regulation Number870.4260
Classification Product Code
DTM  
Date Received12/17/2008
Decision Date 08/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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