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FDA 510(k) Application Details - K021060
Device Classification Name
System, Dialysate Delivery, Single Patient
More FDA Info for this Device
510(K) Number
K021060
Device Name
System, Dialysate Delivery, Single Patient
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON, MA 02420-9192 US
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Contact
NICHOLE RIEK
Other 510(k) Applications for this Contact
Regulation Number
876.5820
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Classification Product Code
FKP
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More FDA Info for this Product Code
Date Received
04/02/2002
Decision Date
11/13/2002
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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