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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 K001250
Device Name APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
Applicant
ASAHI MEDICAL CO., LTD.
1801 ROCKVILLE PIKE PIKE
SUITE 300
ROCKVILLE,  MD  20852
Applicant Contact DAVID L WEST
Correspondent
ASAHI MEDICAL CO., LTD.
1801 ROCKVILLE PIKE PIKE
SUITE 300
ROCKVILLE,  MD  20852
Correspondent Contact DAVID L WEST
Regulation Number876.5860
Classification Product Code
KDI  
Date Received04/19/2000
Decision Date 08/16/2000
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
Recalls CDRH Recalls
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