| K-number | K831831 |
| Device name | TRULIFE SILICONE BREAST FORM |
| Applicant | Medeering, Ltd. |
| Product code | GBI |
| Device class | Class I |
| Decision date | Jun 30, 1983 |
| Decision | Substantially Equivalent |
| Regulation | 878.3800 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov