The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Modern Medical Resectoscope Electrodes.
| Device ID | K091511 |
| 510k Number | K091511 |
| Device Name: | MODERN MEDICAL RESECTOSCOPE ELECTRODES |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. 35 TAI LIN PAI RD. Kwai Chung, Hong Kong, CN |
| Contact | Eugene Yeung |
| Correspondent | Eugene Yeung MODERN MEDICAL EQUIPMENT MFG., LTD. 35 TAI LIN PAI RD. Kwai Chung, Hong Kong, CN |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-22 |
| Decision Date | 2010-01-15 |