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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 K243929
Device Name Oligio X
Applicant
Wontech Co., Ltd.
64, Techno 8-Ro, Yuseong-Gu
64, Techno 8-Ro, Yuseong-Gu,  KR 34028
Applicant Contact Hyun Sik Yoon
Correspondent
Wontech Co., Ltd.
64, Techno 8-Ro, Yuseong-Gu
64, Techno 8-Ro, Yuseong-Gu,  KR 34028
Correspondent Contact Hyun Sik Yoon
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/20/2024
Decision Date 01/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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