| Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
| 510(k) Number |
K810277 |
| Device Name |
PREGELLED DISPOS. ELECTROSURG. GROUND EL |
| Applicant |
| Conmedcorp |
| 3040 E. River Rd. |
|
Dayton,
OH
45439
|
|
| Correspondent |
| Conmedcorp |
| 3040 E. River Rd. |
|
Dayton,
OH
45439
|
|
| Regulation Number | 878.4400 |
| Classification Product Code |
|
| Date Received | 02/02/1981 |
| Decision Date | 03/11/1981 |
| 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
|