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FDA 510(k) Application Details - K231749
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K231749
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
Shenzhenshi Sincoheren S&T Development Co., Ltd.
Floor 4, No 2 plant, No. 14, Zhongxing Road, Xiuxin
Community, Kengzi Street, Pingshan District
Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact
Cai Jialong
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/15/2023
Decision Date
10/19/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K231749
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