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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 -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 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
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