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FDA 510(k) Application Details - K021732
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K021732
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
DIDECO S.P.A.
195 WEST ST.
WALTHAM, MA 02451-1163 US
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Contact
BARRY SALL
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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
05/24/2002
Decision Date
11/04/2002
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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