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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 K012178
Device Name FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
Original Applicant
FRESENIUS HEMOTECHNOLOGY, INC.
6675 185th ave. ne, suite 100
redmond,  WA  98052
Original Contact tom trotter
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/12/2001
Decision Date 07/23/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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