The following data is part of a premarket notification filed by Modern Medical Equipment Manufacturing, Ltd. with the FDA for Single Use Hand Switch Monopolar Forceps With Smoke Evacuation, Single Use Hand Switch Bipolar Forceps With Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps.
| Device ID | K210315 |
| 510k Number | K210315 |
| Device Name: | Single Use Hand Switch Monopolar Forceps With Smoke Evacuation, Single Use Hand Switch Bipolar Forceps With Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 |
| Contact | Jerry Cheung |
| Correspondent | Philip Hung Modern Medical Equipment Manufacturing, LTD. Unit A, 10/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street, Kwai Chung N.t., 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 | 2021-02-03 |
| Decision Date | 2022-03-17 |