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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 K033328
Device Name NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
Applicant
Novosci Corp.
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381
Applicant Contact LEANN LATHAM
Correspondent
Novosci Corp.
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381
Correspondent Contact LEANN LATHAM
Regulation Number870.4290
Classification Product Code
DTL  
Subsequent Product Code
DWF  
Date Received10/16/2003
Decision Date 01/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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