← Product Code [GBJ](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ) · K934970

# DUET (K934970)

_Trulife , Ltd. · GBJ · Dec 10, 1993 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ/K934970

## Device Facts

- **Applicant:** Trulife , Ltd.
- **Product Code:** [GBJ](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ.md)
- **Decision Date:** Dec 10, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3750
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ/K934970](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ/K934970)

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