DUET
Device Facts
| Record ID | K934970 |
|---|---|
| Device Name | DUET |
| Applicant | Trulife , Ltd. |
| Product Code | GBJ · General, Plastic Surgery |
| Decision Date | Dec 10, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3750 |
| Device Class | Class 1 |
Regulatory Classification
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.