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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 K032040
Device Name IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
Applicant
DIDECO S.P.A.
195 WEST ST.
WALTHAM,  MA  02451 -1163
Applicant Contact BARRY SALL
Correspondent
DIDECO S.P.A.
195 WEST ST.
WALTHAM,  MA  02451 -1163
Correspondent Contact BARRY SALL
Regulation Number870.4360
Classification Product Code
KFM  
Date Received07/01/2003
Decision Date 07/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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