The following data is part of a premarket notification filed by Modern Medical Equipment Manufacturing Limited with the FDA for Disposable General Electrode.
| Device ID | K152059 |
| 510k Number | K152059 |
| Device Name: | Disposable General Electrode |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED 35-41 TAI LIN PAI RD., UNIT F, 5TH FL., FOLD KING IND. BLDG, KWAI CHUNG, N.T. Hong Kong, TW |
| Contact | Thomas Chan Tsz Fung |
| Correspondent | Thomas Chan Tsz Fung MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED 35-41 TAI LIN PAI RD., UNIT F, 5TH FL., GOLD KING KWAI CHUNG, N.T. Hong Kong, TW |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-24 |
| Decision Date | 2016-04-21 |
| Summary: | summary |