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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 K232223
Device Name PlaDuo System
Applicant
ShenB Co., Ltd.
Shenb Bldg., 148 Seongsui-Ro, Seongdong-Gu
Seoul,  KR
Applicant Contact Sunny Kang
Correspondent
Hoy and Associates Regulatory Consultants
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Aubrey Thompson
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/26/2023
Decision Date 10/24/2023
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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