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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K130280
Device Name CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
Applicant
Terumo Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact GARRY A COURTNEY, MBA, RAC
Correspondent
Terumo Corporation
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact GARRY A COURTNEY, MBA, RAC
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received02/05/2013
Decision Date 03/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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