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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 K131611
Device Name FRESENIUS DRY ACID DISSOLUTION UNITS
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 WINTER ST
WALTHAM,  MA  02451
Applicant Contact DENISE OPPERMANN
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
920 WINTER ST
WALTHAM,  MA  02451
Correspondent Contact DENISE OPPERMANN
Regulation Number876.5820
Classification Product Code
KPO  
Date Received06/03/2013
Decision Date 08/29/2013
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 No
Recalls CDRH Recalls
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