Device Classification Name |
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
|
510(k) Number |
K930439 |
Device Name |
MARCO SURGISCOPE OPERATION MICROSCOPES |
Applicant |
MARCO OPHTHALMIC, INC. |
11825 CENTRAL PKWY. |
JACKSONVILLE,
FL
32224
|
|
Applicant Contact |
WAYNE STARING |
Correspondent |
MARCO OPHTHALMIC, INC. |
11825 CENTRAL PKWY. |
JACKSONVILLE,
FL
32224
|
|
Correspondent Contact |
WAYNE STARING |
Regulation Number | 878.4700
|
Classification Product Code |
|
Date Received | 01/26/1993 |
Decision Date | 07/22/1993 |
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
|