The following data is part of a premarket notification filed by Lccs Products Limited with the FDA for Lccs Disposable Rf Electrode, Lccs Reusable Rf Electrode.
| Device ID | K152642 |
| 510k Number | K152642 |
| Device Name: | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | LCCS PRODUCTS LIMITED FLAT A, 9/F ., HENNESSY PLAZA, 164-166 HENNESSY ROAD, WANCHAI Hong Kong, CN |
| Contact | James Lin |
| Correspondent | Field Fu SHENZHEN JOYANTECH CONSULTING CO., LTD. NO. 55 SHIZHOU MIDDLE ROAD, NANSHAN DISTRICT Shenzhen, CN Gd755 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2016-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 64895233605249 | K152642 | 000 |
| 14895233605114 | K152642 | 000 |
| 14895233605121 | K152642 | 000 |
| 14895233605138 | K152642 | 000 |
| 14895233605145 | K152642 | 000 |
| 64895233605317 | K152642 | 000 |
| 64895233605324 | K152642 | 000 |
| 64895233605331 | K152642 | 000 |
| 64895233605348 | K152642 | 000 |
| 64895233605010 | K152642 | 000 |
| 64895233605027 | K152642 | 000 |
| 64895233605034 | K152642 | 000 |
| 64895233605218 | K152642 | 000 |
| 64895233605225 | K152642 | 000 |
| 64895233605232 | K152642 | 000 |
| 04895233605049 | K152642 | 000 |