The following data is part of a premarket notification filed by Axis Surgical Technologies, Inc with the FDA for C-mor Visualization Device.
| Device ID | K093717 |
| 510k Number | K093717 |
| Device Name: | C-MOR VISUALIZATION DEVICE |
| Classification | Arthroscope |
| Applicant | AXIS SURGICAL TECHNOLOGIES, INC 325 E. MIDDLEFIELD RD Mountain View, CA 94043 |
| Contact | James Farnworth |
| Correspondent | James Farnworth AXIS SURGICAL TECHNOLOGIES, INC 325 E. MIDDLEFIELD RD Mountain View, CA 94043 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-02 |
| Decision Date | 2010-03-02 |
| Summary: | summary |