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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 K071494
Device Name CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
Applicant
TERUMO CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact GARY COURTNEY
Correspondent
TERUMO CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact GARY COURTNEY
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received05/30/2007
Decision Date 07/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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