← Product Code [LXI](/submissions/SU/subpart-e%E2%80%94surgical-devices/LXI) · K890445

# PERSONAL ALERT ASSIST DEVICE (K890445)

_Silent Call Corp. · LXI · May 19, 1989 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXI/K890445

## Device Facts

- **Applicant:** Silent Call Corp.
- **Product Code:** [LXI](/submissions/SU/subpart-e%E2%80%94surgical-devices/LXI.md)
- **Decision Date:** May 19, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4820
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXI/K890445](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LXI/K890445)

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