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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 K191293
Device Name LCCS VC-S RF Cannula
Applicant
LCCS Products Limited
Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai
Ying Pun
Hong Kong,  CN
Applicant Contact Nick XU
Correspondent
LCCS Products Limited
Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai
Ying Pun
Hong Kong,  CN
Correspondent Contact Nick XU
Regulation Number882.4725
Classification Product Code
GXI  
Date Received05/14/2019
Decision Date 01/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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