Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K955442 |
Device Name |
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM |
Applicant |
KOWA OPTIMED, INC. |
700 THIRTEENTH STREET, N.W. |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
SAMIA N RODRIGUEZ |
Correspondent |
KOWA OPTIMED, INC. |
700 THIRTEENTH STREET, N.W. |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
SAMIA N RODRIGUEZ |
Regulation Number | 886.1120
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/28/1995 |
Decision Date | 01/03/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|