← Product Code [KZE](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE) · K861687

# BIOJECTOR SYRINGE SYSTEM (K861687)

_Bioject, Inc. · KZE · Apr 23, 1987 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K861687

## Device Facts

- **Applicant:** Bioject, Inc.
- **Product Code:** [KZE](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE.md)
- **Decision Date:** Apr 23, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5430
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K861687](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZE/K861687)

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