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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 K140205
Device Name PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
Applicant
Teleflexmedical, Inc.
2917 Weck Dr.
P.O. Box 12600
Research Triangle Park,  NC  27709
Applicant Contact HOLLY KORNEGAY
Correspondent
Teleflexmedical, Inc.
2917 Weck Dr.
P.O. Box 12600
Research Triangle Park,  NC  27709
Correspondent Contact HOLLY KORNEGAY
Regulation Number868.5830
Classification Product Code
CAC  
Date Received01/27/2014
Decision Date 10/23/2014
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
Recalls CDRH Recalls
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