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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K022450
Device Name INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
Applicant
Dideco S.P.A.
195 W. St.
Waltham,  MA  02451
Applicant Contact BARRY SALL
Correspondent
Dideco S.P.A.
195 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received07/26/2002
Decision Date 10/22/2002
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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