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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 K252211
Device Name Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
Applicant
Cnc Technologies
E1101, Gwang Myeong Technopark, 60, Haan-Ro
Gwangmyeong-Si,  KR 14353
Applicant Contact Euna Choi
Correspondent
Cti Co., Ltd.
A-1712, 43, Iljik-Ro
Gwangmyeong-Si,  KR 14353
Correspondent Contact Jeong Mi Won
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/15/2025
Decision Date 08/11/2025
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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