← Product Code [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF) · K834165

# SYRINGE (K834165)

_Elfa Trading Co. · FMF · Dec 13, 1983 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K834165

## Device Facts

- **Applicant:** Elfa Trading Co.
- **Product Code:** [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF.md)
- **Decision Date:** Dec 13, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5860
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K834165](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K834165)

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