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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 K130520
Device Name CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
Applicant
Ashitaka Factory of Terumo Corp.
150 Maimaigi-Cho
Fujinomiya Shizuoka,  JP 418-0015
Applicant Contact EILEEN DORSEY
Correspondent
Ashitaka Factory of Terumo Corp.
150 Maimaigi-Cho
Fujinomiya Shizuoka,  JP 418-0015
Correspondent Contact EILEEN DORSEY
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received02/28/2013
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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