| 510(k) Number |
K844320 |
| Device Name |
MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE |
| Applicant |
| Belgium Surgical Co. |
| 341 Masonic Temple Bldg. |
|
Portsmouth,
OH
45662
|
|
| Applicant Contact |
DENNIS E SEXTON |
| Correspondent |
| Belgium Surgical Co. |
| 341 Masonic Temple Bldg. |
|
Portsmouth,
OH
45662
|
|
| Correspondent Contact |
DENNIS E SEXTON |
| Date Received | 11/06/1984 |
| Decision Date | 11/29/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|