FDA 510(k) Application Details - K233120

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K233120
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Chungwoo Co., Ltd.
614, 2, Gasadigital 1-ro
Guemcheon-gu 13201 KR
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Contact Su Jin Lee
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 09/27/2023
Decision Date 05/23/2024
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 K233120


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