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FDA 510(k)

MADgic Laryngo-Tracheal Mucosal Atomization Device

K-Number: K153470 · 2016-08-19

ApplicantTeleflex Medical
Decision Date2016-08-19
Product CodeCCT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MADgic Laryngo-Tracheal Mucosal Atomization Device is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K153470. The device is classified under product code CCT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MADgic Laryngo-Tracheal Mucosal Atomization Device?

MADgic Laryngo-Tracheal Mucosal Atomization Device is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Teleflex Medical. The 510(k) number is K153470.

When did MADgic Laryngo-Tracheal Mucosal Atomization Device receive FDA 510(k) clearance?

MADgic Laryngo-Tracheal Mucosal Atomization Device received FDA 510(k) clearance on 2016-08-19, under 510(k) number K153470.

Who is the listed applicant for MADgic Laryngo-Tracheal Mucosal Atomization Device?

The FDA 510(k) record lists Teleflex Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MADgic Laryngo-Tracheal Mucosal Atomization Device?

The FDA product code for MADgic Laryngo-Tracheal Mucosal Atomization Device is CCT.

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Related Devices (Code: CCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240114UltraEzAir® (UEA1A)Dualams, Inc., Dba AirkorK172956Medicant Mucosal AtomizerMedica Holdings, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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