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FDA 510(k) Application Details - K221743
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K221743
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
Jiangsu Bonss Medical Technology Co., Ltd.
Building #7, No. 898 China Medical City Avenue
Hailing District
Taizhou 225316 CN
Other 510(k) Applications for this Company
Contact
Feir Zeng
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
06/15/2022
Decision Date
09/07/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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