Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K141954 |
Device Name |
XCEL 455 SLIT LAMP |
Applicant |
REICHERT, INC. |
3362 WALDEN AVE. |
DEPEW,
NY
14043
|
|
Applicant Contact |
THOMAS M HECKMANN |
Correspondent |
REICHERT, INC. |
3362 WALDEN AVE. |
DEPEW,
NY
14043
|
|
Correspondent Contact |
THOMAS M HECKMANN |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 07/18/2014 |
Decision Date | 10/15/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|