AMOENA BREAST FORMS
Device Facts
| Record ID | K853822 |
|---|---|
| Device Name | AMOENA BREAST FORMS |
| Applicant | Coloplast Corp. |
| Product Code | GBI · General, Plastic Surgery |
| Decision Date | Sep 30, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3800 |
| Device Class | Class 1 |
Regulatory Classification
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.
