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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K864265
Device Name HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI
Applicant
Dial Medical of Florida, Inc.
P.O. Drawer 85
1990 Industrial Dr. (32724)
Deland,  FL  32721
Applicant Contact GARY BROWN
Correspondent
Dial Medical of Florida, Inc.
P.O. Drawer 85
1990 Industrial Dr. (32724)
Deland,  FL  32721
Correspondent Contact GARY BROWN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received10/29/1986
Decision Date 03/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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