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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 K990159
Device Name DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
Applicant
DYNAMIC TECHNOLOGY CORP.
SCIENCE-BASED INDUSTRIAL PARK
HSINCHU,  TW 300
Applicant Contact YAW C YANG
Correspondent
DYNAMIC TECHNOLOGY CORP.
SCIENCE-BASED INDUSTRIAL PARK
HSINCHU,  TW 300
Correspondent Contact YAW C YANG
Regulation Number876.5820
Classification Product Code
FJI  
Date Received01/19/1999
Decision Date 04/19/1999
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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