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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 K120333
Device Name PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
Applicant
Gambro Renal Products
1845 Mason Ave.
Daytona Beach,  FL  32117 -5102
Applicant Contact FEI LAW
Correspondent
Gambro Renal Products
1845 Mason Ave.
Daytona Beach,  FL  32117 -5102
Correspondent Contact FEI LAW
Regulation Number876.5820
Classification Product Code
KPO  
Date Received02/03/2012
Decision Date 05/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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