The following data is part of a premarket notification filed by Emcision Ltd. with the FDA for Habib Endohpb.
| Device ID | K180165 |
| 510k Number | K180165 |
| Device Name: | Habib EndoHPB |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | EMcision Ltd. DuCane Road London, GB W12 0hs |
| Contact | Francois Poulin |
| Correspondent | Louis-paul Marin LOK North America Inc. 2025 Michelin Laval, CA H71 5b7 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-03-20 |
| Summary: | summary |