FDA 510(k) Application Details - K171707

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K171707
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Gowoonsesang Cosmetics Co., Ltd
(Seohyeon-dong, 4, 5F Cocoplaza)
20, Seohyeon-ro 210beon-gil, Bundang-gu
Seongnam-si 13591 KR
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Contact Kyeong Tai Ko
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 06/08/2017
Decision Date 08/08/2017
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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