The following data is part of a premarket notification filed by Roseburg Sa with the FDA for S.t.a.c.e.m. External Breast Prosthesis Mammary.
| Device ID | K872714 |
| 510k Number | K872714 |
| Device Name: | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY |
| Classification | Material, External Aesthetic Restoration, Used With Adhesive |
| Applicant | ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Contact | Darienne Moyer |
| Correspondent | Darienne Moyer ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Product Code | GBI |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-10 |
| Decision Date | 1987-07-21 |