Device Classification Name |
device, analysis, anterior segment
|
510(k) Number |
K191051 |
Device Name |
ARGOS |
Applicant |
SANTEC CORPORATION |
5823 Ohkusa-Nenjozaka |
komaki,
JP
485-0802
|
|
Applicant Contact |
changho chong |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
warren,
NJ
07059
|
|
Correspondent Contact |
dave yungvirt |
Regulation Number | 886.1850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/19/2019 |
Decision Date | 05/16/2019 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|