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 |