UTC 3mL Medication Cartridge— 510(k) K230718

Substantially Equivalent

Gilero, LLC

FDA 510(k) clearance K230718 for UTC 3mL Medication Cartridge, Substantially Equivalent on 2023-06-15. Applicant: Gilero, LLC. Device class: 2.

Clearance details

Applicant: Gilero, LLC
Product code: Code MRZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2023-03-15
Decision date: 2023-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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