← Product Code [EJI](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI) · K823536

# INTRALIG (K823536)

_Miltex Instrument Co. · EJI · Dec 28, 1982 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K823536

## Device Facts

- **Applicant:** Miltex Instrument Co.
- **Product Code:** [EJI](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI.md)
- **Decision Date:** Dec 28, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6770
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K823536](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K823536)

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