FDA 510(k) Application Details - K232703

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K232703
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Jiangsu Hope Biomedical Science&Technology Co., Ltd.
No.3 Building, Hi-tech Innovation Service Center,
Jiangdu District
Yangzhou 225211 CN
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Contact Shaote Geng
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 09/05/2023
Decision Date 03/06/2024
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 K232703


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