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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K110782
Device Name XVAC
Applicant
Sorin Group Italia S.R.L.
195 W. St.
Waltham,  MA  02451
Applicant Contact BARRY SALL
Correspondent
Sorin Group Italia S.R.L.
195 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/21/2011
Decision Date 04/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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