Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K100439 |
Device Name |
MEDIWORKS SLIT LAMP |
Applicant |
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. |
1485 ANDREW DR |
SUITE G |
CLAREMONT,
CA
91711
|
|
Applicant Contact |
LISA ZHANG |
Correspondent |
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. |
1485 ANDREW DR |
SUITE G |
CLAREMONT,
CA
91711
|
|
Correspondent Contact |
LISA ZHANG |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 02/17/2010 |
Decision Date | 07/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|