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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K050890
Device Name ECC.O SYSTEM
Applicant
Dideco S.R.L.
195 W. St.
Waltham,  MA  02451
Applicant Contact BARRY SALL
Correspondent
Dideco S.R.L.
195 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number870.4360
Classification Product Code
KFM  
Date Received04/08/2005
Decision Date 05/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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