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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 K973291
Device Name DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES
Applicant
Dynamic Technology Corp.
6833 Saint Lawrence St.
Plano,  TX  75024
Applicant Contact ERIC LUO
Correspondent
Dynamic Technology Corp.
6833 Saint Lawrence St.
Plano,  TX  75024
Correspondent Contact ERIC LUO
Regulation Number876.5820
Classification Product Code
FJI  
Date Received09/02/1997
Decision Date 12/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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