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FDA 510(k) Application Details - K191293
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K191293
Device Name
Probe, Radiofrequency Lesion
Applicant
LCCS Products Limited
Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai
Ying Pun
Hong Kong CN
Other 510(k) Applications for this Company
Contact
Nick XU
Other 510(k) Applications for this Contact
Regulation Number
882.4725
More FDA Info for this Regulation Number
Classification Product Code
GXI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2019
Decision Date
01/24/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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