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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Sorbent Regenerated
510(k) Number K864179
Device Name BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR
Applicant
Ash Medical Systems, Inc.
2701 B Kent Ave.
West Lafayette,  IN  47906
Applicant Contact STEPHEN R ASH
Correspondent
Ash Medical Systems, Inc.
2701 B Kent Ave.
West Lafayette,  IN  47906
Correspondent Contact STEPHEN R ASH
Regulation Number876.5600
Classification Product Code
FKT  
Date Received10/24/1986
Decision Date 12/11/1986
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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