The following data is part of a premarket notification filed by Emcision, Ltd. with the FDA for Habib Endoblate.
| Device ID | K072383 |
| 510k Number | K072383 |
| Device Name: | HABIB ENDOBLATE |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | EMCISION, LTD. LIVER SURGERY, HAMMERSMITH HOSPITAL CAMPUS, DU CANE RD. London, Uk, GB W12 Ohs |
| Contact | Nagy Habib |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-08-24 |
| Decision Date | 2007-11-29 |
| Summary: | summary |