Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K232992 |
Device Name |
10THERMA |
Applicant |
Tentech Inc. |
3F, Hyungkyung Building, 611, Seolleung-ro, Gangnam-gu, |
Seoul,
KR
06103
|
|
Applicant Contact |
Dongok Han |
Correspondent |
BT Solutions, Inc. |
Unit 904, Eonju-ro 86-gil 5, Gangnam-gu |
Seoul,
KR
06210
|
|
Correspondent Contact |
Do Hyun Kim |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/22/2023 |
Decision Date | 12/20/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|