FDA 510(k) Application Details - K221743

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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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
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Contact Feir Zeng
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Regulation Number 878.4400

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Classification Product Code GEI
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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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