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K Number
K000482

Validate with FDA (Live)

Device Name
MODIFICATION TO AUTOJECT MINI
Manufacturer
OWEN MUMFORD, LTD.
Date Cleared
2000-03-06

(21 days)

Product Code
KZH
Regulation Number
880.6920
Type
Traditional
Panel
General Hospital
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K050434,K073476
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 880.6920 Syringe needle introducer.

(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).