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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 K040498
Device Name MYSHELL
Applicant
Sedat S.A.
4 Harvard Pl., # 1
Charlestown,  MA  02129
Applicant Contact PETER C WOOD
Correspondent
Sedat S.A.
4 Harvard Pl., # 1
Charlestown,  MA  02129
Correspondent Contact PETER C WOOD
Regulation Number870.4290
Classification Product Code
DTL  
Date Received02/26/2004
Decision Date 07/02/2004
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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