FDA 510(k) Application Details - K163530

Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System

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510(K) Number K163530
Device Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant BAXTER HEALTHCARE CORP
7601 Northland Drive
Suite 170
Brooklyn Park, MN 55428 US
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Contact Chris Scavotto
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Regulation Number 876.5860

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Classification Product Code KDI
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Date Received 12/16/2016
Decision Date 05/03/2017
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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