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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K000977
Device Name COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
Applicant
OLSON MEDICAL SALES, INC.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact GARY A COURTNEY
Correspondent
OLSON MEDICAL SALES, INC.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact GARY A COURTNEY
Regulation Number870.4240
Classification Product Code
DTR  
Date Received03/27/2000
Decision Date 03/23/2001
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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