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FDA 510(k)

LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)

K-Number: K002255 · 2000-09-18

ApplicantWolfe Tory Medical, Inc.
Decision Date2000-09-18
Product CodeCCT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) is the device name listed in this FDA 510(k) record. The listed applicant is Wolfe Tory Medical, Inc.. It received FDA 510(k) clearance on 2000-09-18 under 510(k) number K002255. 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 LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)?

LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) is a medical device that received FDA 510(k) clearance on 2000-09-18. The listed applicant is Wolfe Tory Medical, Inc.. The 510(k) number is K002255.

When did LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) receive FDA 510(k) clearance?

LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) received FDA 510(k) clearance on 2000-09-18, under 510(k) number K002255.

Who is the listed applicant for LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)?

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

What is the FDA product code for LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)?

The FDA product code for LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) is CCT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Wolfe Tory Medical, Inc. as applicant

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.

K021044MADETTK990556ESOPHAGEAL INTUBATION DETECTORK945745ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)K942628ESOPHAGEAL INTUBATION DETECTOR BULB

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, LLCK153470MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex MedicalK093584EZ-MISTERN.M. Beale Co., Inc.K070596TOPICAL APPLICATORSharn, Inc.K894755ASTRA DISPOSABLE SPRAY CANNULAAstra Pharmaceutical Products, Inc.

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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