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FDA 510(k) Application Details - K153344
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K153344
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
Asahi Kasei Medical Co., Ltd.
1-105 Kanda Jinbocho
Chiyoda-ku 101-8101 JP
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Contact
Hidenobu Nakazawa
Other 510(k) Applications for this Contact
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
11/19/2015
Decision Date
12/17/2015
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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