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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
Original Applicant
TERUMO Corporation
125 blue ball road
elkton,  MD  21921
Original 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
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