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510(k) K201936

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL by Gilero, LLC — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2021
Date Received
July 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

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