Device Classification Name |
microscope, specular
|
510(k) Number |
K173980 |
Device Name |
Specular Microscope CEM-530 |
Applicant |
Nidek Co., Ltd. |
34-14 Maehama, Hiroishi-cho |
Gamagori,
JP
443-0038
|
|
Applicant Contact |
Yoneji Mizuno |
Correspondent |
Ora, Inc. |
300 Brickstone Square |
Andover,
MA
01810
|
|
Correspondent Contact |
Ryan Bouchard |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 12/29/2017 |
Decision Date | 03/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02276638
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|