The following data is part of a premarket notification filed by 3d Line Usa, Inc. with the FDA for Stereotactic Body Frame, Model Cod. 70-1a.
| Device ID | K031631 |
| 510k Number | K031631 |
| Device Name: | STEREOTACTIC BODY FRAME, MODEL COD. 70-1A |
| Classification | Accelerator, Linear, Medical |
| Applicant | 3D LINE USA, INC. 11419 CROWNRIDGE RD., STE.15 Owings Mills, MD 21117 |
| Contact | Nader Salehi |
| Correspondent | Nader Salehi 3D LINE USA, INC. 11419 CROWNRIDGE RD., STE.15 Owings Mills, MD 21117 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-27 |
| Decision Date | 2003-07-18 |
| Summary: | summary |