The following data is part of a premarket notification filed by 3d Line Usa, Inc. with the FDA for 3d Line Sterotactic Hardware Accessories.
| Device ID | K011255 |
| 510k Number | K011255 |
| Device Name: | 3D LINE STEROTACTIC HARDWARE ACCESSORIES |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | 3D LINE USA, INC. 2807 OLD COURT RD. Baltimore, MD 21208 |
| Contact | Karen H Rigamonti |
| Correspondent | Karen H Rigamonti 3D LINE USA, INC. 2807 OLD COURT RD. Baltimore, MD 21208 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-24 |
| Decision Date | 2001-12-20 |