Device Classification Name |
powered tongue scraper
|
510(k) Number |
K181986 |
Device Name |
Klinly Ultrasonic Tongue Cleaner |
Applicant |
KEA Products Ltd |
10C, Meyer Ind. Bldg, 2 Chong Yip Street |
Kwun Tong,
HK
00000
|
|
Applicant Contact |
Michael Schmidt |
Correspondent |
Robert T. Bock Consultancy LLC |
66 Drovers Lane |
Brewster,
NY
10509
|
|
Correspondent Contact |
Robert T. Bock |
Regulation Number | 872.6865
|
Classification Product Code |
|
Date Received | 07/25/2018 |
Decision Date | 09/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|