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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 K963098
Device Name PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
Applicant
Deknatel, Inc.
600 Airport Rd.
Fall River,  MA  02720
Applicant Contact DEAN E CIPORKIN
Correspondent
Deknatel, Inc.
600 Airport Rd.
Fall River,  MA  02720
Correspondent Contact DEAN E CIPORKIN
Regulation Number868.5830
Classification Product Code
CAC  
Date Received08/09/1996
Decision Date 11/08/1996
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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