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FDA 510(k) Application Details - K070177
Device Classification Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
More FDA Info for this Device
510(K) Number
K070177
Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 WINTER ST.
WALTHAM, MA 02451 US
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Contact
JANET C KAY
Other 510(k) Applications for this Contact
Regulation Number
876.5820
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Classification Product Code
KPO
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More FDA Info for this Product Code
Date Received
01/18/2007
Decision Date
03/29/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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