The following data is part of a premarket notification filed by Btl Industries, Inc with the FDA for Xp300.
| Device ID | K143109 |
| 510k Number | K143109 |
| Device Name: | XP300 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BTL INDUSTRIES, INC 47 Loring Drive Framington, MA 01702 |
| Contact | Jan Zarsky |
| Correspondent | Deirdre Barrow EMERGO GROUP 816 CONGRESS AVENUE SUITE 1400 Austin, TX 78701 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-29 |
| Decision Date | 2015-03-06 |