FDA 510(k) Application Details - K173112

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K173112
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Sejong Medical Co., Ltd.
11, Sinchon 2-ro
Paju-si 10880 KR
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Contact Yoojung Choi
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 09/29/2017
Decision Date 11/21/2017
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



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