The following data is part of a premarket notification filed by Emcision, Ltd. with the FDA for Habib Laparoscopic Hexablate.
| Device ID | K073687 |
| 510k Number | K073687 |
| Device Name: | HABIB LAPAROSCOPIC HEXABLATE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EMCISION, LTD. DU CANE ROAD London, GB W12 0nn |
| Contact | Nagy Habib |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-12-28 |
| Decision Date | 2008-01-09 |
| Summary: | summary |