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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Bldg.
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 Number882.4725
Classification Product Code
GXI  
Date Received08/04/2011
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
Predetermined Change
Control Plan Authorized		 No
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