The following data is part of a premarket notification filed by Btl Industries, Inc with the FDA for Xp1100 Rf.
| Device ID | K152731 |
| 510k Number | K152731 |
| Device Name: | XP1100 RF |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BTL INDUSTRIES, INC 47 Loring Drive Framingham, MA 01702 |
| Contact | Jan Zarsky |
| Correspondent | Michail M Pankratov MMP MEDICAL ASSOCIATES LLC 16 APPLETON ST Waltham, MA 02453 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-22 |
| Decision Date | 2016-07-20 |
| Summary: | summary |