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FDA 510(k) Application Details - K082515
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K082515
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
ASAHI KASEI MEDICAL CO., LTD.
1801 ROCKVILLE PIKE, SUITE 300
ROCKVILLE, MD 20852 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
09/02/2008
Decision Date
10/03/2008
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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