← Product Code [HAE](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE) · K943635

# ULTRA-LINE RONGEUR (K943635)

_V. Mueller Neuro/Spine · HAE · Dec 7, 1994 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K943635

## Device Facts

- **Applicant:** V. Mueller Neuro/Spine
- **Product Code:** [HAE](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE.md)
- **Decision Date:** Dec 7, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4840
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K943635](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K943635)

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