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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 K902741
Device Name VASCUMED EZ Y-CONNECTOR
Applicant
Vascumed Systems
5 Norther Blvd.
Amherst,  NH  03031
Applicant Contact PETER PETRUS
Correspondent
Vascumed Systems
5 Norther Blvd.
Amherst,  NH  03031
Correspondent Contact PETER PETRUS
Regulation Number870.4290
Classification Product Code
DTL  
Date Received06/22/1990
Decision Date 11/01/1990
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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