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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 K863661
Device Name MEDCOMP DISPOSABLE MANIFOLD SYSTEM
Applicant
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact RACHEL D RICHARDSON
Correspondent
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact RACHEL D RICHARDSON
Regulation Number870.4290
Classification Product Code
DTL  
Date Received09/18/1986
Decision Date 09/29/1986
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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