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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 K870270
Device Name MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.
Applicant
ASH MEDICAL SYSTEMS, INC.
2701 B KENT AVE.
WEST LAFAYETTE,  IN  47906
Applicant Contact ASH, M.D.
Correspondent
ASH MEDICAL SYSTEMS, INC.
2701 B KENT AVE.
WEST LAFAYETTE,  IN  47906
Correspondent Contact ASH, M.D.
Regulation Number876.5600
Classification Product Code
FKT  
Date Received01/27/1987
Decision Date 02/25/1987
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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