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FDA 510(k) Application Details - K021615
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K021615
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN RD., MPR-A2E
MCGAW PARK, IL 60085-6730 US
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DAVID E CURTIN
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Regulation Number
876.5860
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Classification Product Code
KDI
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Date Received
05/16/2002
Decision Date
11/18/2002
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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