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510(k) K212262

PCA Syringe Sets by Baxter Healthcare Corporation — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2022
Date Received
July 20, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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