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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K002238
Device Name CAPIOX SX HARDSHELL RESERVOIR 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 Number870.4400
Classification Product Code
DTN  
Date Received07/24/2000
Decision Date 08/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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