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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 K032994
Device Name GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
Applicant
Gemore Technology Co, Ltd.
11 Floor, # 29-5, Sec. 2
Chung Cheng E. Rd.
Tan Shui, Taipei Hsien,  TW
Applicant Contact BODEN S.P. LAI
Correspondent
Gemore Technology Co, Ltd.
11 Floor, # 29-5, Sec. 2
Chung Cheng E. Rd.
Tan Shui, Taipei Hsien,  TW
Correspondent Contact BODEN S.P. LAI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/25/2003
Decision Date 12/16/2003
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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