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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 K012178
Device Name FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
Applicant
Fresenius Hemotechnology, Inc.
6675 185th Ave. NE, Suite 100
Redmond,  WA  98052
Applicant Contact TOM TROTTER
Correspondent
Fresenius Hemotechnology, Inc.
6675 185th Ave. NE, Suite 100
Redmond,  WA  98052
Correspondent Contact TOM TROTTER
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/12/2001
Decision Date 07/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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