K230718

Substantially Equivalent

UTC 3mL Medication Cartridge

Applicant: Gilero, LLC
Product code: MRZ
Advisory panel: General Hospital
Date received: 2023-03-15
Decision date: 2023-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.