FDA 510(k) Application Details - K232460

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K232460
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Shenzhen Mecun Medical Supply Co., Ltd.
2nd Level, 2nd Building, Fuqiang S&T Park 6 Ailian
Industrial Park,Zhugushi,Wulian Community, Longgang District
Shenzhen 518000 CN
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Contact Bo Zheng
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 08/15/2023
Decision Date 10/11/2023
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 K232460


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