The following data is part of a premarket notification filed by Modern Medical Equipment Manufacturing, Ltd. with the FDA for Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde.
| Device ID | K192542 |
| 510k Number | K192542 |
| Device Name: | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Modern Medical Equipment Manufacturing, LTD. Flat A, 11/F., Mai Wah Ind. B;dg., 1-7, Kawi Chung, N.T., Hong Kong Hong Kong, CN |
| Contact | Jerry Cheung |
| Correspondent | Jerry Cheung Modern Medical Equipment Manufacturing, LTD. Flat A, 11/F., Mai Wah Ind. B;dg., 1-7, Kawi Chung, N.T., Hong Kong Hong Kong, CN |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2020-06-16 |