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FDA 510(k) Application Details - K041428
Device Classification Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
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510(K) Number
K041428
Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
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
876.5820
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Classification Product Code
KPO
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Date Received
05/28/2004
Decision Date
08/27/2004
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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