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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 K851431
Device Name HEMODIALYSIS CONCENTRATE ADDITIVES
Applicant
Dana Laboratories
2700 Peterson Way-63c
Costa Mesa,  CA  92626
Applicant Contact RONALD GOODMAN
Correspondent
Dana Laboratories
2700 Peterson Way-63c
Costa Mesa,  CA  92626
Correspondent Contact RONALD GOODMAN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received04/10/1985
Decision Date 06/12/1985
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
Recalls CDRH Recalls
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