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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K984586
Device Name FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
Applicant
Fresenius Hemotechnology, Inc.
110 Mason Cir. Suite A
Concord,  CA  94520
Applicant Contact VIRGINIA R SINGER
Correspondent
Fresenius Hemotechnology, Inc.
110 Mason Cir. Suite A
Concord,  CA  94520
Correspondent Contact VIRGINIA R SINGER
Regulation Number870.4400
Classification Product Code
DTN  
Date Received12/24/1998
Decision Date 06/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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