K-number	K201936
Device name	SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
Applicant	Gilero, LLC
Product code	KPE
Device class	Class II
Decision date	May 6, 2021
Decision	Substantially Equivalent
Regulation	880.5025

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Source

View the full FDA submission: accessdata.fda.gov

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SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

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