Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K200372 |
Device Name |
Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil |
Applicant |
Modern Medical Equipment Manufacturing, Ltd. |
Flat A, 11/F., Mai Wah Ind. Bldg., 1-7, Kwai Chung N.T. |
Hong Kong |
Hong Kong,
CN
|
|
Applicant Contact |
Jerry Cheung |
Correspondent |
Modern Medical Equipment Manufacturing, Ltd. |
Flat A, 11/F., Mai Wah Ind. Bldg., 1-7, Kwai Chung N.T. |
Hong Kong |
Hong Kong,
CN
|
|
Correspondent Contact |
Jerry Cheung |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 02/14/2020 |
Decision Date | 11/30/2020 |
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
|
|
|