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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
Applicant
Fresenius Hemotechnology, Inc.
110 Mason Circle Suite A
Concord,  CA  94520 -1238
Applicant Contact VIRGINIA R SINGER
Correspondent
Fresenius Hemotechnology, Inc.
110 Mason Circle Suite A
Concord,  CA  94520 -1238
Correspondent Contact VIRGINIA R SINGER
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/25/1998
Decision Date 02/01/1999
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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