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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K182355
Device Name Secret RF Smartcure Applicator with electrodes
Applicant
Ilooda Co,., Ltd.
120, Jangan-Ro 458 Beon-Gil, Jangan-Gu
Suwon-Si,  KR
Applicant Contact Yun-Jung Ha
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
KCW   ONQ   OUH  
Date Received08/30/2018
Decision Date 09/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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