The following data is part of a premarket notification filed by Modern Medical Equipment Manufacturing Limited with the FDA for Single Use Arthroscopic Electrode (with Pencil).
| Device ID | K170703 |
| 510k Number | K170703 |
| Device Name: | Single Use Arthroscopic Electrode (with Pencil) |
| Classification | Arthroscope |
| 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 | Jerry Cheung |
| Correspondent | Jerry Cheung 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-08 |
| Decision Date | 2018-05-31 |
| Summary: | summary |