Device Classification Name |
Probe, Radiofrequency Lesion
|
510(k) Number |
K112231 |
Device Name |
LCCS INSULATED SPINAL NEEDLE (RF CANNULA) |
Applicant |
LCCS PRODUCTS LIMITED |
05C FUJAI KANGLE BUILDING |
NANSHAN DISTRICT |
SHENZHEN, GUANGDONG,
CN
518000
|
|
Applicant Contact |
FIELD FU |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 882.4725
|
Classification Product Code |
|
Date Received | 08/04/2011 |
Decision Date | 08/19/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|