← Product Code [BYP](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP) · K770586

# UNIVERSAL MOUTHPIECE, #750 (K770586)

_Surgicot, Inc. · BYP · Apr 5, 1977 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K770586

## Device Facts

- **Applicant:** Surgicot, Inc.
- **Product Code:** [BYP](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP.md)
- **Decision Date:** Apr 5, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5620
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K770586](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYP/K770586)

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