The following data is part of a premarket notification filed by Emcision Ltd. with the FDA for Habib Eus Rfa.
| Device ID | K161305 |
| 510k Number | K161305 |
| Device Name: | Habib EUS RFA |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EMCISION LTD. DU CANE ROAD London, GB W12 0hs |
| Contact | Francois Poulin |
| Correspondent | Me Louis-paul Marin LOK North America Inc. 2025 Michelin Laval, CA H7l 5b7 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-10 |
| Decision Date | 2016-07-07 |
| Summary: | summary |