The following data is part of a premarket notification filed by Top-rank Health Care Co., Ltd with the FDA for Electrosurgical Disposable Grounding Pads.
| Device ID | K160366 |
| 510k Number | K160366 |
| Device Name: | Electrosurgical Disposable Grounding Pads |
| Classification | Electrosurgical Patient Return Electrode |
| Applicant | TOP-RANK Health Care Co., Ltd Checun Village, Dongguan Street, Shangyu District Shaoxing, CN 312352 |
| Contact | Liubo Shen |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | ODR |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-09 |
| Decision Date | 2016-08-19 |
| Summary: | summary |