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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical Patient Return Electrode
510(k) Number K160366
Device Name Electrosurgical disposable grounding pads
Applicant
Top-Rank Health Care Co., Ltd.
Checun Village, Dongguan St., Shangyu District
Shaoxing,  CN 312352
Applicant Contact Liubo Shen
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4400
Classification Product Code
ODR  
Date Received02/09/2016
Decision Date 08/19/2016
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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