Device Classification Name |
powder, porcelain
|
510(k) Number |
K191902 |
Device Name |
Razor, Everest, U&C Liquid |
Applicant |
U&C International Co., Ltd. |
RM 1F/2F, 13, Digital-ro 27-gil, Guro-gu |
Seoul,
KR
|
|
Applicant Contact |
Jong-min Kim |
Correspondent |
LK Consulting Group USA, Inc. |
1150 Roosevelt, STE 200 |
Irvine,
CA
92620
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 07/16/2019 |
Decision Date | 10/11/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|