Device Classification Name |
Cord, Retraction
|
510(k) Number |
K171577 |
Device Name |
Smartcord, Smartcord X |
Applicant |
EASTDENT Co., Ltd |
601-1 Sogong B/D, 64 Gugal-ro, Giheung-gu |
Yongin-si,
KR
16972
|
|
Applicant Contact |
Hyonsu Kim |
Correspondent |
EASTDENT Co., Ltd |
601-1 Sogong B/D, 64 Gugal-ro, Giheung-gu |
Yongin-si,
KR
16972
|
|
Correspondent Contact |
Hyonsu Kim |
Classification Product Code |
|
Date Received | 05/30/2017 |
Decision Date | 05/03/2018 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|