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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K072276
Device Name SUBDERMAL NEEDLE ELECTRODES
Applicant
Xian Friendship Electronics Co., Ltd.
Rm.1606 Bldg. 1, Jianxiang Yua
# 229 Bei Si Huan Zhong Rd.
Haidian District, Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Xian Friendship Electronics Co., Ltd.
Rm.1606 Bldg. 1, Jianxiang Yua
# 229 Bei Si Huan Zhong Rd.
Haidian District, Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received08/15/2007
Decision Date 05/16/2008
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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