The following data is part of a premarket notification filed by X-sten Corp. with the FDA for X-sten Mild Tool Kit, Model Mtk-0001.
| Device ID | K062038 |
| 510k Number | K062038 |
| Device Name: | X-STEN MILD TOOL KIT, MODEL MTK-0001 |
| Classification | Arthroscope |
| Applicant | X-STEN CORP. 2362 QUME DRIVE SUITE D San Jose, CA 95131 -1841 |
| Contact | Timothy M Reeves |
| Correspondent | Timothy M Reeves X-STEN CORP. 2362 QUME DRIVE SUITE D San Jose, CA 95131 -1841 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-19 |
| Decision Date | 2006-12-19 |
| Summary: | summary |