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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K011537
Device Name DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS
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 Number876.5860
Classification Product Code
KDI  
Date Received05/18/2001
Decision Date 01/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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