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FDA 510(k) Application Details - K042938
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K042938
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
GAMBRO RENAL PRODUCTS
10810 WEST COLLINS AVE.
LAKEWOOD, CO 80215 US
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Contact
THOMAS B DOWELL
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Regulation Number
876.5860
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Classification Product Code
KDI
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More FDA Info for this Product Code
Date Received
10/25/2004
Decision Date
01/06/2005
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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