Device Classification Name |
material, impression
|
510(k) Number |
K180565 |
Device Name |
PEAK NS033CF, PEAK NS017CF |
Applicant |
Neosil Co., Ltd |
63, Gongdanseo-ro 18beon-gil, Geumjeong-gu |
Gyeongsangnam-do,
KR
46332
|
|
Applicant Contact |
Woo-ryong Ryou |
Correspondent |
Onbix Corporation |
#821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu |
Seoul,
KR
06523
|
|
Correspondent Contact |
Yang Ho Dong |
Regulation Number | 872.3660
|
Classification Product Code |
|
Date Received | 03/05/2018 |
Decision Date | 06/13/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|