The following data is part of a premarket notification filed by X-sten Corp. with the FDA for Vertos Medical Mild Device Kit.
| Device ID | K093062 |
| 510k Number | K093062 |
| Device Name: | VERTOS MEDICAL MILD DEVICE KIT |
| Classification | Arthroscope |
| Applicant | X-STEN CORP. 1193 SHERMAN ST. Alameda, CA 94501 -1841 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs X-STEN CORP. 1193 SHERMAN ST. Alameda, CA 94501 -1841 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2010-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327651683 | K093062 | 000 |