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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 K153265
Device Name New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
Applicant
New Deantronics Taiwan , Ltd.
12f, # 51, Sec. 4, Chong Yang Rd., Tu Cheng Dist.
New Taipei City,  TW 23675
Applicant Contact Jane Liu
Correspondent
L.W. Ward and Associates, Inc.
4655 Kirkwood Ct.
Boulder,  CO  80301
Correspondent Contact Lewis Ward
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/12/2015
Decision Date 01/05/2016
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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