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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 K820743
Device Name HOLLOW FIBER DIALYZERS
Applicant
Terumo Medical Corp.
120 New England Ave.
Piscataway,  NJ  08854
Applicant Contact DAVID MARSH
Correspondent
Terumo Medical Corp.
120 New England Ave.
Piscataway,  NJ  08854
Correspondent Contact DAVID MARSH
Regulation Number876.5820
Classification Product Code
FJI  
Date Received03/19/1982
Decision Date 06/23/1982
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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