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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
Predetermined Change
Control Plan Authorized		 No
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