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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 K160735
Device Name CATSmart
Applicant
FRESENIUS KABI AG
ELSE-KRONER-STRASSE 1
Bad Homburg,  DE 61352
Applicant Contact Barry G. Hicks
Correspondent
FRESENIUS KABI USA
THREE CORPORATE DRIVE
Lake Zurich,  IL  60047
Correspondent Contact Barry G. Hicks
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/17/2016
Decision Date 09/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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