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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 K863402
Device Name MEDI-PLAST DISPOSABLE MANIFOLD
Applicant
Medi-Plast Intl., Inc.
8601 Dunwoody Pl., NE
Suite 330
Atlanta,  GA  30338
Applicant Contact KATHLEEN A LUMBERG
Correspondent
Medi-Plast Intl., Inc.
8601 Dunwoody Pl., NE
Suite 330
Atlanta,  GA  30338
Correspondent Contact KATHLEEN A LUMBERG
Regulation Number870.4290
Classification Product Code
DTL  
Date Received09/03/1986
Decision Date 10/22/1986
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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