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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 K954284
Device Name MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)
Applicant
Medi-Plast Intl., Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Medi-Plast Intl., Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number870.4290
Classification Product Code
DTL  
Date Received08/30/1995
Decision Date 02/12/1996
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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