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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 K193004
Device Name Monopolar Cord
Applicant
New Deantronics Taiwan , Ltd.
12f., #51, Sec.4, Chong Yang Rd., Tucheng Dist.
New Taipei City,  TW 23675
Applicant Contact Jane Liu
Correspondent
Coombs Medical Device Consulting, Inc.
1100 Pacific Marina, Suite #806
Alameda,  CA  94501
Correspondent Contact Craig J. Coombs
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/28/2019
Decision Date 12/19/2019
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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