The following data is part of a premarket notification filed by Lccs Products Limited with the FDA for Lccs Insulated Spinal Needle (rf Cannula).
| Device ID | K112231 |
| 510k Number | K112231 |
| Device Name: | LCCS INSULATED SPINAL NEEDLE (RF CANNULA) |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | LCCS PRODUCTS LIMITED 05C FUJAI KANGLE BUILDING NANSHAN DISTRICT Shenzhen, Guangdong, CN 518000 |
| Contact | Field Fu |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-08-04 |
| Decision Date | 2011-08-19 |