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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K160081
Device Name TENS Electrodes
Applicant
Cathay Manufacturing Corp.
#328,Xishe Rd.,Maogang Town,Songjiang Area
Shanghai,  CN 201607
Applicant Contact Ren Ren
Correspondent
Shanghai Yuntao Management Consultant
Rm. 202, # 14, Lane 986, Gaosi Rd.
Pudong District
Shanghai,  CN 201203
Correspondent Contact Fan Tao
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/15/2016
Decision Date 10/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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