The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Stavip 3000.
| Device ID | K864436 |
| 510k Number | K864436 |
| Device Name: | STAVIP 3000 |
| Classification | Apparatus, Electrophoresis, For Clinical Use |
| Applicant | ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Contact | Jean-pierre Laclau |
| Correspondent | Jean-pierre Laclau ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Product Code | JJN |
| CFR Regulation Number | 862.2485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-12 |
| Decision Date | 1987-03-16 |