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FDA 510(k) Application Details - K072232
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K072232
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
GAMBRO RENAL PRODUCTS, INC.
14143 DENVER WEST PARKWAY
SUITE 400
LAKEWOOD, CO 80401 US
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KAE MILLER
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Regulation Number
876.5860
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Classification Product Code
KDI
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Date Received
08/10/2007
Decision Date
09/07/2007
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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