The following data is part of a premarket notification filed by Foley & Lardner with the FDA for Dynasty U1-33 Agm.
| Device ID | K942311 |
| 510k Number | K942311 |
| Device Name: | DYNASTY U1-33 AGM |
| Classification | Components, Wheelchair |
| Applicant | FOLEY & LARDNER 3000 K STREET, N.W. SUITE 500 Washington, DC 20007 -5109 |
| Contact | Ilene K Gotts |
| Correspondent | Ilene K Gotts FOLEY & LARDNER 3000 K STREET, N.W. SUITE 500 Washington, DC 20007 -5109 |
| Product Code | KNN |
| CFR Regulation Number | 890.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-13 |
| Decision Date | 1994-11-07 |