EMERGENCY TRACHEOSTOMY KIT— 510(k) K823872

Name: FDA 510(k) clearance K823872
Creator: U.S. Food and Drug Administration
Published: 1983-01-21

Substantially Equivalent

Omnicon Medical Corp.

FDA 510(k) clearance K823872 for EMERGENCY TRACHEOSTOMY KIT, Substantially Equivalent on 1983-01-21. Applicant: Omnicon Medical Corp.. Device class: 1.

Clearance details

Applicant: Omnicon Medical Corp.
Product code: Code EWC
Device class: Class 1
Regulation: 21 CFR 874.1060
Advisory panel: Ear, Nose, Throat
Date received: 1982-12-27
Decision date: 1983-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.