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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 K903835
Device Name ACETATE-FREE DIALYSLATE SOLUTION
Applicant
Physio, Inc.
53 Bishops Dr.
Aston,  PA  19014
Applicant Contact EUGENE A ELLIS
Correspondent
Physio, Inc.
53 Bishops Dr.
Aston,  PA  19014
Correspondent Contact EUGENE A ELLIS
Regulation Number876.5820
Classification Product Code
KPO  
Date Received08/21/1990
Decision Date 07/05/1991
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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