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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Dialysis, Single Needle (Co-Axial Flow)
510(k) Number K820859
Device Name COAXIAL DUAL FLOW CATHETER
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Regulation Number876.5540
Classification Product Code
LBW  
Date Received03/29/1982
Decision Date 04/16/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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