The following data is part of a premarket notification filed by Btl Industries Ltd with the FDA for Exilis, Model 5000.
| Device ID | K092191 |
| 510k Number | K092191 |
| Device Name: | EXILIS, MODEL 5000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BTL INDUSTRIES LTD 1705 S. CAPITAL OF TEXAS HWY. SUITE 500 Austin, TX 78746 |
| Contact | Richard Vincins |
| Correspondent | Richard Vincins BTL INDUSTRIES LTD 1705 S. CAPITAL OF TEXAS HWY. SUITE 500 Austin, TX 78746 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2009-11-25 |
| Summary: | summary |