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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 K982813
Device Name NATURALYTE, MODEL # 08-4004-1
Applicant
Kaybath, Inc.
95-547 Ukee St., #110
Waipahu,  HI  96797
Applicant Contact BONNIE NAKAYAMA
Correspondent
Kaybath, Inc.
95-547 Ukee St., #110
Waipahu,  HI  96797
Correspondent Contact BONNIE NAKAYAMA
Regulation Number876.5820
Classification Product Code
KPO  
Date Received08/11/1998
Decision Date 11/06/1998
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
Predetermined Change
Control Plan Authorized		 No
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