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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
510(k) Number K112426
Device Name XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
Applicant
XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.
JIANXIANG YUAN #209
BEI SI HU ZHONG RD
HAIDIAN DIS., BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.
JIANXIANG YUAN #209
BEI SI HU ZHONG RD
HAIDIAN DIS., BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number874.1820
Classification Product Code
ETN  
Date Received08/23/2011
Decision Date 04/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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