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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 K150489
Device Name EOS PMP, EOS PMP Integrated
Applicant
Sorin Group Italia S.R.L.
86, Via Statale 12 Nord
Mirandola,  IT 41037
Applicant Contact LUIGI VECCHI
Correspondent
Parexel Consulting, LLC
195 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY S. SALL RAC, FRAPS
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received02/25/2015
Decision Date 06/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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