| Device Classification Name |
Forceps
|
| 510(k) Number |
K874023 |
| Device Name |
LEVTECH CLAMP APPLIER |
| Applicant |
| Levtech, Inc. |
| P.O. Box 516 |
|
Jacksonville,
FL
32201
|
|
| Applicant Contact |
LEVON PENTECOST |
| Correspondent |
| Levtech, Inc. |
| P.O. Box 516 |
|
Jacksonville,
FL
32201
|
|
| Correspondent Contact |
LEVON PENTECOST |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 10/02/1987 |
| Decision Date | 11/06/1987 |
| 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
|
|
|