The following data is part of a premarket notification filed by Modern Medical Equipment Manufacturing Limited with the FDA for Single Use Micro Electrode (brass With Gold Plated Shaft); Single Use Micro Electrode (stainless Steel Shaft).
| Device ID | K163442 |
| 510k Number | K163442 |
| Device Name: | Single Use Micro Electrode (Brass With Gold Plated Shaft); Single Use Micro Electrode (Stainless Steel Shaft) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Modern Medical Equipment Manufacturing Limited 35-41 Tai Lin Pai Rd, Unit F 5th Fl, Gold King Ind., Bldg., Kwai Chung, N.T. Hong Kong, CN |
| Contact | Thomas Tsz Fung Chan |
| Correspondent | Samson Woo Modern Medical Equipment Manufacturing Limited 35-41 Tai Lin Pai Rd, Unit F 5th Fl, Gold King Ind., Bldg., 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 | 2016-12-08 |
| Decision Date | 2017-09-28 |
| Summary: | summary |