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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 K031554
Device Name S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
Applicant
Genzyme Biosurgery
600 Airport Rd.
Fall River,  MA  02720
Applicant Contact DENISE LIMA
Correspondent
Genzyme Biosurgery
600 Airport Rd.
Fall River,  MA  02720
Correspondent Contact DENISE LIMA
Regulation Number868.5830
Classification Product Code
CAC  
Date Received05/19/2003
Decision Date 07/25/2003
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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