← Product Code [MMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK) · K950897

# BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) (K950897)

_Biosystems · MMK · Aug 24, 1995 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K950897

## Device Facts

- **Applicant:** Biosystems
- **Product Code:** [MMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK.md)
- **Decision Date:** Aug 24, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5570
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K950897](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K950897)

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