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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K013813
Device Name MODIFICATION TO:APEX MEDICAL IF-4100
Applicant
Apex Medical Corp.
10th Floor , # 31, Lane 169,
Kang Ning St.
Shi-Chih, Taipei Hsien,  TW
Applicant Contact ALAN CHANGE
Correspondent
Apex Medical Corp.
10th Floor , # 31, Lane 169,
Kang Ning St.
Shi-Chih, Taipei Hsien,  TW
Correspondent Contact ALAN CHANGE
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
LIH  
Date Received11/16/2001
Decision Date 12/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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