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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 K961416
Device Name DIALYSIS MIXING & HOLDING TANK
Applicant
Dial Medical Supply
1990 Industrial Dr.
Deland,  FL  32724
Applicant Contact MATTHEW M HULL
Correspondent
Dial Medical Supply
1990 Industrial Dr.
Deland,  FL  32724
Correspondent Contact MATTHEW M HULL
Regulation Number876.5820
Classification Product Code
FIN  
Date Received04/12/1996
Decision Date 08/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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