← Product Code [HBG](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG) · K915546

# PS MEDICAL VENTRICULOSTOMY KIT (K915546)

_Pudenz-Schulte Medical Research Corp. · HBG · Dec 30, 1991 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K915546

## Device Facts

- **Applicant:** Pudenz-Schulte Medical Research Corp.
- **Product Code:** [HBG](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG.md)
- **Decision Date:** Dec 30, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4300
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K915546](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K915546)

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