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FDA 510(k) Application Details - K162887
Device Classification Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
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510(K) Number
K162887
Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant
Baxter Healthcare Corporation
32650 North Wilson Road
Round Lake, IL 60073 US
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Contact
Kristen Bozzelli
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Regulation Number
876.5820
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Classification Product Code
KPO
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More FDA Info for this Product Code
Date Received
10/17/2016
Decision Date
01/06/2017
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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