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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 K030497
Device Name FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
Applicant
FRESENIUS MEDICAL CARE
95 HAYDEN AVE.
LEXINGTON,  MA  02420
Applicant Contact ART EILINSFELD
Correspondent
FRESENIUS MEDICAL CARE
95 HAYDEN AVE.
LEXINGTON,  MA  02420
Correspondent Contact ART EILINSFELD
Regulation Number876.5820
Classification Product Code
KPO  
Date Received02/19/2003
Decision Date 05/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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