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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 K071387
Device Name FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
Applicant
Fresenius Medical Care North America
920 Winter St.
Waltham,  MA  02451
Applicant Contact JANET C KAY
Correspondent
Fresenius Medical Care North America
920 Winter St.
Waltham,  MA  02451
Correspondent Contact JANET C KAY
Regulation Number876.5820
Classification Product Code
KPO  
Date Received05/18/2007
Decision Date 06/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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