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FDA 510(k) Application Details - K211035
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K211035
Device Name
Subsystem, Water Purification
Applicant
Baxter Healthcare Corporation
25212 W. Illinois Route 120
Round Lake, IL 60073 US
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Contact
Carina Pforr
Other 510(k) Applications for this Contact
Regulation Number
876.5665
More FDA Info for this Regulation Number
Classification Product Code
FIP
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More FDA Info for this Product Code
Date Received
04/07/2021
Decision Date
10/19/2021
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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