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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K033987
Device Name D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
Applicant
Dideco S.P.A.
195 W. St.
Waltham,  MA  02451 -1163
Applicant Contact BARRY SALL
Correspondent
Dideco S.P.A.
195 W. St.
Waltham,  MA  02451 -1163
Correspondent Contact BARRY SALL
Regulation Number870.4260
Classification Product Code
DTM  
Date Received12/23/2003
Decision Date 01/08/2004
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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