The following data is part of a premarket notification filed by Foley & Lardner with the FDA for Dynasty Gc 12550 (gell/cell).
| Device ID | K942310 |
| 510k Number | K942310 |
| Device Name: | DYNASTY GC 12550 (GELL/CELL) |
| 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 |