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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tank, holding, dialysis
510(k) Number K060333
Device Name DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
Applicant
DIALYSIS SERVICES, INC.
130 ELDER DR.
SPRINGFIELD,  TN  37172
Applicant Contact MIKE STERLING
Correspondent
DIALYSIS SERVICES, INC.
130 ELDER DR.
SPRINGFIELD,  TN  37172
Correspondent Contact MIKE STERLING
Regulation Number876.5820
Classification Product Code
FIN  
Date Received02/09/2006
Decision Date 09/08/2006
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
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