The following data is part of a premarket notification filed by Trac Medical, Inc. with the FDA for Orthotrac Coaxial Laser.
| Device ID | K933431 |
| 510k Number | K933431 |
| Device Name: | ORTHOTRAC COAXIAL LASER |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | TRAC MEDICAL, INC. 4106 WAKE FOREST RD. Raliegh, NC 27609 |
| Contact | Terry N Williams |
| Correspondent | Terry N Williams TRAC MEDICAL, INC. 4106 WAKE FOREST RD. Raliegh, NC 27609 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-14 |
| Decision Date | 1993-10-05 |
| Summary: | summary |