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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 K861177
Device Name CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
Applicant
TERUMO MEDICAL CORP.
P.O. BOX 605
ELKTON,  MD  21912
Applicant Contact HARALD JACOBY
Correspondent
TERUMO MEDICAL CORP.
P.O. BOX 605
ELKTON,  MD  21912
Correspondent Contact HARALD JACOBY
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/31/1986
Decision Date 05/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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