| Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
| 510(k) Number |
K951245 |
| Device Name |
VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY |
| Applicant |
| Vidamed, Inc. |
| 1380 Willow Rd.Ve |
|
Menlo Park,
CA
94025
|
|
| Applicant Contact |
NOEL MESSENGER |
| Correspondent |
| Vidamed, Inc. |
| 1380 Willow Rd.Ve |
|
Menlo Park,
CA
94025
|
|
| Correspondent Contact |
NOEL MESSENGER |
| Regulation Number | 878.4400 |
| Classification Product Code |
|
| Date Received | 03/17/1995 |
| Decision Date | 06/09/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|