Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K082031 |
Device Name |
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES |
Applicant |
APPASAMY ASSOCIATES |
20, SBI OFFICERS COLONY |
1ST STREET |
ARUMBAKKAM, CHENNAI,
IN
600 106
|
|
Applicant Contact |
R.N. KASTHURI |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 07/17/2008 |
Decision Date | 07/31/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|