The following data is part of a premarket notification filed by Advanced Osseous Technologies with the FDA for System Ten Model 100 Surgical System.
| Device ID | K900003 |
| 510k Number | K900003 |
| Device Name: | SYSTEM TEN MODEL 100 SURGICAL SYSTEM |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | ADVANCED OSSEOUS TECHNOLOGIES C/O CHARLES L. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose ADVANCED OSSEOUS TECHNOLOGIES C/O CHARLES L. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-02 |
| Decision Date | 1990-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304004009 | K900003 | 000 |
| 00880304000452 | K900003 | 000 |