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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 K844663
Device Name ASAHI NEW PAN-SERIES HEMOFILTERS
Applicant
Asahi Medical Co., Ltd.
C/O Advocacy Services Group
1825 I St., NW, Suite 400
Washington,  DC  20006
Applicant Contact RICHARD T NEY
Correspondent
Asahi Medical Co., Ltd.
C/O Advocacy Services Group
1825 I St., NW, Suite 400
Washington,  DC  20006
Correspondent Contact RICHARD T NEY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received11/30/1984
Decision Date 01/18/1985
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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