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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K854960
Device Name DISPOSABLE MANIFOLD
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Applicant Contact GORDON BARTLETT
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Correspondent Contact GORDON BARTLETT
Regulation Number870.4290
Classification Product Code
DTL  
Date Received12/11/1985
Decision Date 02/10/1986
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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