FDA 510(k) Application Details - K240657

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K240657
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant LivsMed Inc.
304, D-dong, 700, Pangyo-ro, Bundang-gu
Seongnam-si 13516 KR
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Contact Hyeonbin Chung
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 03/08/2024
Decision Date 06/06/2024
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 K240657


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