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FDA 510(k) Application Details - K030497
Device Classification Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
More FDA Info for this Device
510(K) Number
K030497
Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant
FRESENIUS MEDICAL CARE
95 HAYDEN AVE.
LEXINGTON, MA 02420 US
Other 510(k) Applications for this Company
Contact
ART EILINSFELD
Other 510(k) Applications for this Contact
Regulation Number
876.5820
More FDA Info for this Regulation Number
Classification Product Code
KPO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/19/2003
Decision Date
05/20/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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