← Product Code [KCZ](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KCZ) · K951324

# MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS (K951324)

_Maxol Limited L.C. · KCZ · May 26, 1995 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KCZ/K951324

## Device Facts

- **Applicant:** Maxol Limited L.C.
- **Product Code:** [KCZ](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KCZ.md)
- **Decision Date:** May 26, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3800
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KCZ/K951324](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KCZ/K951324)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com