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FDA 510(k) Application Details - K193482
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K193482
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
Baxter Healthcare Corporation
7601 Northland Drive
Brooklyn Park, MN 55428 US
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Contact
Christopher Scavotto
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Regulation Number
876.5860
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Classification Product Code
KDI
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Date Received
12/17/2019
Decision Date
03/13/2020
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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