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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K212787
Device Name GT5 conductive & abrasive gel
Applicant
Wuhan Greentek Pty Ltd.
Room 03-2, Floor 3, Dingye Building, Phase III,
International Enterprise Center, Special No. 1, Guanggu Ave
Wuhan,  CN 430074
Applicant Contact Yarong Liu
Correspondent
Wuhan Greentek Pty Ltd.
Room 03-2, Floor 3, Dingye Building, Phase III,
International Enterprise Center, Special No. 1, Guanggu Ave
Wuhan,  CN 430074
Correspondent Contact Yarong Liu
Regulation Number882.1275
Classification Product Code
GYB  
Date Received09/01/2021
Decision Date 11/08/2021
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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