Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K962532 |
Device Name |
RODENSTOCK SLITLAMP (MODEL 5000 & 4000) |
Applicant |
EXPERTECH ASSOC., INC. |
100 MAIN ST. |
SUITE 120 |
CONCORD,
MA
01742
|
|
Applicant Contact |
DAVID M LINK |
Correspondent |
EXPERTECH ASSOC., INC. |
100 MAIN ST. |
SUITE 120 |
CONCORD,
MA
01742
|
|
Correspondent Contact |
DAVID M LINK |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 06/28/1996 |
Decision Date | 07/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|