| Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
| 510(k) Number |
K072126 |
| Device Name |
HABIB VESEAL |
| Applicant |
| Emcision , Ltd. |
| Liver Surgery, Hammersmith |
| Hospital Campus, Du Cane Rd. |
|
London, Uk,
GB
W12 OHS
|
|
| Applicant Contact |
NAGY HABIB |
| Correspondent |
| Underwriters Laboratories, Inc. |
| 455 E. Trimble Rd. |
|
San Jose,
CA
95131 -1230
|
|
| Regulation Number | 878.4400 |
| Classification Product Code |
|
| Date Received | 08/02/2007 |
| Decision Date | 10/02/2007 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
Yes
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|