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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 K963850
Device Name PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
Applicant
Deknatel, Inc.
600 Airport Rd., P.O. Box
2980
Fall River,  MA  02722
Applicant Contact DEAN E CIPORKIN
Correspondent
Deknatel, Inc.
600 Airport Rd., P.O. Box
2980
Fall River,  MA  02722
Correspondent Contact DEAN E CIPORKIN
Regulation Number868.5830
Classification Product Code
CAC  
Date Received09/25/1996
Decision Date 04/22/1997
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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