Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K060869 |
Device Name |
RS-1000 ZOOM SLITLAMP WITH OPTION |
Applicant |
RIGHTMEDICAL PRODUCTS, LLC |
200 EXPRESSWAY COURT |
VIRGINIA BEACH,
VA
23462
|
|
Applicant Contact |
HARUMI KUMAHARA |
Correspondent |
RIGHTMEDICAL PRODUCTS, LLC |
200 EXPRESSWAY COURT |
VIRGINIA BEACH,
VA
23462
|
|
Correspondent Contact |
HARUMI KUMAHARA |
Regulation Number | 886.1850 |
Classification Product Code |
|
Date Received | 03/30/2006 |
Decision Date | 05/11/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|