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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 K251492
Device Name Irrigation Tubing Bipolar Cord Set
Applicant
New Deantronics Taiwan , Ltd.
12f. #51, Sec.4, Zhongyang Rd., Tucheng Dist.,
New Taipei City,  TW 236
Applicant Contact Hung-Kuei Tsai
Correspondent
New Deantronics Taiwan , Ltd.
12f. #51, Sec.4, Zhongyang Rd., Tucheng Dist.,
New Taipei City,  TW 236
Correspondent Contact Hung-Kuei Tsai
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/15/2025
Decision Date 06/29/2026
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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