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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K882129
Device Name SYMBION CENTRIFUGAL BLOOD PUMP MODEL I
Applicant
Symbion, Inc.
350 W. 800 N.
Salt Lake City,  UT  84103
Applicant Contact RICK GAYKOWSKI
Correspondent
Symbion, Inc.
350 W. 800 N.
Salt Lake City,  UT  84103
Correspondent Contact RICK GAYKOWSKI
Regulation Number870.4360
Classification Product Code
KFM  
Date Received05/20/1988
Decision Date 11/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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