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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 K021952
Device Name HIVOX DREAMATE DM-800
Applicant
Hivox Biotek, Inc.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact Ke-Min Jen
Correspondent
Hivox Biotek, Inc.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact Ke-Min Jen
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/13/2002
Decision Date 05/02/2003
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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