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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K092509
Device Name EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
Applicant
Edwards Lifesciences, LLC
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact KAREN JONES
Correspondent
Edwards Lifesciences, LLC
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact KAREN JONES
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/17/2009
Decision Date 10/08/2009
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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