The following data is part of a premarket notification filed by Oldelft Corp. Of America with the FDA for Oldelft Simulix-mc.
| Device ID | K912466 |
| 510k Number | K912466 |
| Device Name: | OLDELFT SIMULIX-MC |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
| Contact | Charles Pattie |
| Correspondent | Charles Pattie OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1991-06-28 |