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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K930503
Device Name CLIRANS WET PACK HOLLOW FIBER DIALYZER
Applicant
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Applicant Contact ALAN B HERSHMAN
Correspondent
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Correspondent Contact ALAN B HERSHMAN
Regulation Number876.5820
Classification Product Code
FJI  
Date Received02/01/1993
Decision Date 03/06/1995
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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