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FDA 510(k) Application Details - K013418
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K013418
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
ASAHI MEDICAL CO., LTD
1801 ROCKVILLE PIKE
SUITE 300
ROCKVILLE, MD 20852-1632 US
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DAVID L WEST
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Regulation Number
876.5860
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Classification Product Code
KDI
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Date Received
10/15/2001
Decision Date
07/09/2002
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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