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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 K982755
Device Name MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
Applicant
Medtronic Blood Management
18501 E. Plaza Dr.
Parker,  CO  80134 -9061
Applicant Contact STEPHEN MCKELVEY
Correspondent
Medtronic Blood Management
18501 E. Plaza Dr.
Parker,  CO  80134 -9061
Correspondent Contact STEPHEN MCKELVEY
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/29/1998
Decision Date 08/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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