The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Poirier Kid-roller Manual Wheelchair.
Device ID | K874317 |
510k Number | K874317 |
Device Name: | POIRIER KID-ROLLER 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 | 1987-10-21 |
Decision Date | 1987-11-17 |