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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Bubble, Cardiopulmonary Bypass
510(k) Number K911632
Device Name CAPIOX(R) BUBBLE TRAP
Applicant
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Applicant Contact GEORGE S MOMODA
Correspondent
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Correspondent Contact GEORGE S MOMODA
Regulation Number870.4205
Classification Product Code
KRL  
Date Received04/11/1991
Decision Date 07/09/1991
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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