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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 K183126
Device Name Electrosurgical accessory
Applicant
New Deantronics Taiwan Ltd
New Taipei City,  TW 23675
Applicant Contact Jane Liu
Correspondent
Coombs Medical Device Consulting, Inc
1193 Sherman St
Alameda,  CA  94501
Correspondent Contact Craig J. Coombs
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/13/2018
Decision Date 05/08/2019
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
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