Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K970414 |
Device Name |
CONFOCAL MICROSCOPE |
Applicant |
CON-S LTD. |
ONE GALLERIA BOULEVARD, |
SUITE 912 |
METAIRIE,
LA
70002
|
|
Applicant Contact |
HERBERT E KAUFMAN, M.D. |
Correspondent |
CON-S LTD. |
ONE GALLERIA BOULEVARD, |
SUITE 912 |
METAIRIE,
LA
70002
|
|
Correspondent Contact |
HERBERT E KAUFMAN, M.D. |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 01/23/1997 |
Decision Date | 07/15/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|