| Device Classification Name |
Tape, Camera, Surgical
|
| 510(k) Number |
K962148 |
| Device Name |
VERGE VIDEOMETER |
| Applicant |
| Verg, Inc. |
| 633 Wellington Crescent |
|
Winnipeg, Manitoba,
CA
R3M 0A8
|
|
| Applicant Contact |
VERNON C TAYLOR |
| Correspondent |
| Verg, Inc. |
| 633 Wellington Crescent |
|
Winnipeg, Manitoba,
CA
R3M 0A8
|
|
| Correspondent Contact |
VERNON C TAYLOR |
| Regulation Number | 878.4160 |
| Classification Product Code |
|
| Date Received | 06/03/1996 |
| Decision Date | 12/20/1996 |
| 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
|
|
|