510kDecisions.com

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 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 SE - Substantially Equivalent
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 N



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact