The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Poirier Manual Wheelchair.
| Device ID | K864790 |
| 510k Number | K864790 |
| Device Name: | POIRIER MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| 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 | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-08 |
| Decision Date | 1986-12-17 |