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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 K032128
Device Name TERUMO AL8X ARTERIAL FILTER WITH X-COATING
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 Received07/10/2003
Decision Date 08/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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