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K Number
K002255

Validate with FDA (Live)

Device Name
LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
Manufacturer
WOLFE TORY MEDICAL, INC.
Date Cleared
2000-09-18

(55 days)

Product Code
CCT
Regulation Number
868.5170
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K031966,K070596,K122023,K153470
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 868.5170 Laryngotracheal topical anesthesia applicator.

(a)
Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.(b)
Classification. Class II (performance standards).