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 |