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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, Transcutaneous, For Pain Relief
510(k) Number K012643
Device Name APEX MEDICAL LCD TENS-VII
Applicant
Apex Medical Corp.
10th Floor , # 31, Lane 169,
Kang Ning St.
Shi-Chih, Taipei Hsien,  TW
Applicant Contact ALAN CHANG
Correspondent
Apex Medical Corp.
10th Floor , # 31, Lane 169,
Kang Ning St.
Shi-Chih, Taipei Hsien,  TW
Correspondent Contact ALAN CHANG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/13/2001
Decision Date 10/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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