Device Classification Name |
powered light based non-laser surgical instrument with thermal effect
|
510(k) Number |
K220794 |
Device Name |
10PL |
Applicant |
Tentech Co. Ltd. |
3F Hyungkyung Building, 611, Seolleung-ro |
Gangnam-gu,
KR
06103
|
|
Applicant Contact |
Lee Dong Gun |
Correspondent |
Tentech Co. Ltd. |
3F Hyungkyung Building, 611, Seolleung-ro |
Gangnam-gu,
KR
06103
|
|
Correspondent Contact |
Lee Dong Gun |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/18/2022 |
Decision Date | 11/10/2022 |
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
|
|
|