← Product Code [HBE](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE) · K905097

# MICRO-AIRE MODEL NUMBER: MK-426 (K905097)

_Micro Surgical Instruments Corp. · HBE · Dec 21, 1990 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE/K905097

## Device Facts

- **Applicant:** Micro Surgical Instruments Corp.
- **Product Code:** [HBE](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE.md)
- **Decision Date:** Dec 21, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4310
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE/K905097](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE/K905097)

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