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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 K070177
Device Name FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES
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 Received01/18/2007
Decision Date 03/29/2007
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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