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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Central Multiple Patient
510(k) Number K834587
Device Name HEMODIAL CONCENTRATE
Applicant
Moana Productions, Inc.
1190 E. 5425 South
Ogden,  UT  84403
Applicant Contact LETANE M FONOTI
Correspondent
Moana Productions, Inc.
1190 E. 5425 South
Ogden,  UT  84403
Correspondent Contact LETANE M FONOTI
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received12/29/1983
Decision Date 04/13/1984
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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