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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K812498
Device Name CLIRANS TE12 HOLLOW FIBER DIALYZER
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Regulation Number876.5820
Classification Product Code
KOC  
Date Received08/31/1981
Decision Date 09/29/1981
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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