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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 K242241
Device Name Sunny
Applicant
ShenB Co., Ltd.
Shenb Tower, 74, Achasan-Ro, Seongdong-Gu
Seoul,  KR
Applicant Contact Sunny Kang
Correspondent
Hoy and Associates Regulatory Consulting
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Aubrey Thompson
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
NFO   PBX  
Date Received07/31/2024
Decision Date 03/19/2025
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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