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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 K073260
Device Name LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
Applicant
Device Partners International
4305 Enterprise Dr.
Suite E
Winston-Salem,  NC  27106
Applicant Contact MONICA E DOUGHERTY
Correspondent
Device Partners International
4305 Enterprise Dr.
Suite E
Winston-Salem,  NC  27106
Correspondent Contact MONICA E DOUGHERTY
Regulation Number870.4290
Classification Product Code
DTL  
Date Received11/20/2007
Decision Date 03/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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