← Product Code [EQJ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EQJ) · K954912

# TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (K954912)

_Trebay Medical Corp. · EQJ · Dec 6, 1995 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQJ/K954912

## Device Facts

- **Applicant:** Trebay Medical Corp.
- **Product Code:** [EQJ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EQJ.md)
- **Decision Date:** Dec 6, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4140
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQJ/K954912](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EQJ/K954912)

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