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FDA 510(k) Application Details - K214016
Device Classification Name
Set, Administration, For Peritoneal Dialysis, Disposable
More FDA Info for this Device
510(K) Number
K214016
Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Applicant
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015 US
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Contact
Maninee Patel
Other 510(k) Applications for this Contact
Regulation Number
876.5630
More FDA Info for this Regulation Number
Classification Product Code
KDJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2021
Decision Date
03/18/2022
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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