← Product Code [GZT](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT) · K830332

# BUDDE-HALO RETRACTOR (K830332)

_Ohio Medical Instrument Co., Inc. · GZT · Mar 2, 1983 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K830332

## Device Facts

- **Applicant:** Ohio Medical Instrument Co., Inc.
- **Product Code:** [GZT](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT.md)
- **Decision Date:** Mar 2, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4800
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K830332](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GZT/K830332)

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