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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 K973378
Device Name C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
Applicant
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK,  CA  94598
Applicant Contact VIRGINIA SINGER
Correspondent
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK,  CA  94598
Correspondent Contact VIRGINIA SINGER
Regulation Number868.5830
Classification Product Code
CAC  
Date Received09/08/1997
Decision Date 11/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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