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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K153045
Device Name SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
Applicant
Easy Med Instrument Co., Ltd.
5/F-6/F, Blk A, Gupo Gongmao Bld
Fengxin Rd., Fengxiang Industrial District
Daliang, Shunde, Foshan,  CN 528300
Applicant Contact Jeffery Wu (Tingjie Wu)
Correspondent
Easy Med Instrument Co., Ltd.
5/F-6/F, Blk A, Gupo Gongmao Bld
Fengxin Rd., Fengxiang Industrial District
Daliang, Shunde, Foshan,  CN 528300
Correspondent Contact Jeffery Wu (Tingjie Wu)
Regulation Number868.2775
Classification Product Code
BXN  
Date Received10/19/2015
Decision Date 05/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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