Device Classification Name |
light, surgical, accessories
|
510(k) Number |
K871034 |
Device Name |
LCA 2000 |
Applicant |
VISTEK CORP. |
4 EAST YANONALI ST. |
SANTA BARBARA,
CA
93101
|
|
Applicant Contact |
JOHN M GIBBONS |
Correspondent |
VISTEK CORP. |
4 EAST YANONALI ST. |
SANTA BARBARA,
CA
93101
|
|
Correspondent Contact |
JOHN M GIBBONS |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 03/17/1987 |
Decision Date | 04/10/1987 |
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
|