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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 K922990
Device Name HEMODIALYSIS BATH
Applicant
Medi-Tech, Inc.
P.O. Box 1531
Mt Carmel,  TN  37645
Applicant Contact RICHARD DEAN
Correspondent
Medi-Tech, Inc.
P.O. Box 1531
Mt Carmel,  TN  37645
Correspondent Contact RICHARD DEAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received06/22/1992
Decision Date 09/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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