Device Classification Name |
photostimulator, ac-powered
|
510(k) Number |
K914163 |
Device Name |
SCOPTOPIC SENSITIVITY TEST-1[SST-1] |
Applicant |
LKC TECHNOLOGIES, INC. |
2 PROFESSIONAL DR., SUITE 222 |
GAITHERSBURG,
MD
20879
|
|
Applicant Contact |
JEROME LEIGHT |
Correspondent |
LKC TECHNOLOGIES, INC. |
2 PROFESSIONAL DR., SUITE 222 |
GAITHERSBURG,
MD
20879
|
|
Correspondent Contact |
JEROME LEIGHT |
Regulation Number | 886.1630
|
Classification Product Code |
|
Date Received | 09/17/1991 |
Decision Date | 10/25/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|