Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K930442 |
Device Name |
MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS |
Applicant |
MARCO OPHTHALMIC, INC. |
11825 CENTRAL PKWY. |
JACKSONVILLE,
FL
32224
|
|
Correspondent |
MARCO OPHTHALMIC, INC. |
11825 CENTRAL PKWY. |
JACKSONVILLE,
FL
32224
|
|
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 01/26/1993 |
Decision Date | 08/09/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|