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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 K843866
Device Name HEMODIALYSATE SOLUTIONS
Applicant
BICARBOLYTE CORP.
P.O. BOX 5766
CHARLOTTESVILLE,  VA  22905
Applicant Contact ROY A ACKERMAN
Correspondent
BICARBOLYTE CORP.
P.O. BOX 5766
CHARLOTTESVILLE,  VA  22905
Correspondent Contact ROY A ACKERMAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received10/02/1984
Decision Date 01/09/1985
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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