← Product Code [BTR](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR) · K830504

# SURGITEK ULTRA-LO CUFF (K830504)

_Mec/Surgitek Products · BTR · Apr 12, 1983 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K830504

## Device Facts

- **Applicant:** Mec/Surgitek Products
- **Product Code:** [BTR](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR.md)
- **Decision Date:** Apr 12, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5730
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K830504](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K830504)

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