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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 K201221
Device Name Electrosurgical Generator
Applicant
New Deantronics Taiwan Ltd
12F., No.51, Sec.4, Zhongyang 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 Received05/06/2020
Decision Date 09/28/2020
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
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