The following data is part of a premarket notification filed by Emcision, Ltd. with the FDA for Habib Eus Rfa.
| Device ID | K150029 |
| 510k Number | K150029 |
| Device Name: | Habib EUS RFA |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EMCISION, LTD. DUCANE ROAD London, GB W12 0hs |
| Contact | Francois Poulin |
| Correspondent | Louis-paul Marin MMA CERTIFICATION INC. 2025 MICHELIN Laval, CA H7l5b7 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-08 |
| Decision Date | 2015-06-24 |
| Summary: | summary |