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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 K043323
Device Name D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
Applicant
DIDECO S.R.L.
195 WEST ST.
WALTHAM,  MA  02451
Applicant Contact BARRY SALL
Correspondent
DIDECO S.R.L.
195 WEST ST.
WALTHAM,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received12/02/2004
Decision Date 02/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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