← Product Code [EQH](/submissions/EN/subpart-e%E2%80%94surgical-devices/EQH) · K812429

# DALE COMBO TRACHEOSTOMY TUBE HOLDER (K812429)

_Dale Medical Products, Inc. · EQH · Sep 23, 1981 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQH/K812429

## Device Facts

- **Applicant:** Dale Medical Products, Inc.
- **Product Code:** [EQH](/submissions/EN/subpart-e%E2%80%94surgical-devices/EQH.md)
- **Decision Date:** Sep 23, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4350
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQH/K812429](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQH/K812429)

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