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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 K984233
Device Name C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE
Original Applicant
FRESENIUS HEMOTECHNOLOGY, INC.
110 mason circle suite a
concord,  CA  94520 1238
Original Contact virginia r singer
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/25/1998
Decision Date 02/01/1999
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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