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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 K013210
Device Name TRUWAVE
Applicant
Dan Med, Inc.
4 W. Dry Creek Circle,
Suite 260
Denver,  CO  80120
Applicant Contact THOMAS SANDGAARD
Correspondent
Dan Med, Inc.
4 W. Dry Creek Circle,
Suite 260
Denver,  CO  80120
Correspondent Contact THOMAS SANDGAARD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/26/2001
Decision Date 04/04/2002
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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