Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K133667 |
Device Name |
SLIT LAMP SL-D701 |
Applicant |
TOPCON CORP. |
5 TIMBER LANE |
NORTH READING,
MA
01864
|
|
Applicant Contact |
MAUREEN O'CONNELL |
Correspondent |
TOPCON CORP. |
5 TIMBER LANE |
NORTH READING,
MA
01864
|
|
Correspondent Contact |
MAUREEN O'CONNELL |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 11/29/2013 |
Decision Date | 08/26/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|