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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 K083834
Device Name TERUMO PALL AL6X ARTERIAL FILTER
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact EILEEN DORSEY
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact EILEEN DORSEY
Regulation Number870.4260
Classification Product Code
DTM  
Date Received12/23/2008
Decision Date 04/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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