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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
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