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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 K981043
Device Name DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL
Applicant
Solution Technologies
4825 S. 850 E.
South Ogden,  UT  84403
Applicant Contact WILLIAM J GRISWOLD, JR
Correspondent
Solution Technologies
4825 S. 850 E.
South Ogden,  UT  84403
Correspondent Contact WILLIAM J GRISWOLD, JR
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/20/1998
Decision Date 05/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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