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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 K052253
Device Name MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
Applicant
Gambro Renal Products
1845 Mason Ave.
Daytona Beach,  FL  32117
Applicant Contact FEI LAW
Correspondent
Gambro Renal Products
1845 Mason Ave.
Daytona Beach,  FL  32117
Correspondent Contact FEI LAW
Regulation Number876.5820
Classification Product Code
KPO  
Date Received08/18/2005
Decision Date 11/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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