| Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
| 510(k) Number |
K001262 |
| Device Name |
THERMAL CAUTERY FORCEPS |
| Applicant |
| Starion Instruments |
| 20665 4th St. |
|
Saratoga,
CA
95070
|
|
| Applicant Contact |
BRIAN GRIGSBY |
| Correspondent |
| Starion Instruments |
| 20665 4th St. |
|
Saratoga,
CA
95070
|
|
| Correspondent Contact |
BRIAN GRIGSBY |
| Regulation Number | 878.4400 |
| Classification Product Code |
|
| Date Received | 04/19/2000 |
| Decision Date | 06/14/2000 |
| 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
|