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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 K960006
Device Name C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
Applicant
FRESENIUS AG
53 KENNEDY RD.
FOSTER,  RI  02825
Applicant Contact ANNETTE M FAGNANT
Correspondent
FRESENIUS AG
53 KENNEDY RD.
FOSTER,  RI  02825
Correspondent Contact ANNETTE M FAGNANT
Regulation Number868.5830
Classification Product Code
CAC  
Date Received01/02/1996
Decision Date 07/31/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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