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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 K053284
Device Name MAGBODY DT-600
Applicant
Durtech System Corp.
3f, # 27, Lane 381
Fu-The 1st Rd.
His-Chih Taipei,  TW 221
Applicant Contact ADA LIN
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/25/2005
Decision Date 03/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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