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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 K112525
Device Name D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
Applicant
Parexel International
195 W. St.
Waltham,  MA  02451
Applicant Contact BARRY SALL
Correspondent
Parexel International
195 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number870.4260
Classification Product Code
DTM  
Date Received08/31/2011
Decision Date 09/29/2011
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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