The following data is part of a premarket notification filed by Integration Diagnostics Ltd with the FDA for Osstell Mentor Rfa.
| Device ID | K033689 |
| 510k Number | K033689 |
| Device Name: | OSSTELL MENTOR RFA |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | INTEGRATION DIAGNOSTICS LTD 719 A STREET NE Washington, DC 20002 |
| Contact | Trish Landry |
| Correspondent | Trish Landry INTEGRATION DIAGNOSTICS LTD 719 A STREET NE Washington, DC 20002 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2004-02-26 |
| Summary: | summary |