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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 K962951
Device Name MODEL HS-2 TENS DEVICE
Applicant
Technalithics Laboratories, Inc.
7003 Woodway Dr., Suite 315
Waco,  TX  76712
Correspondent
Technalithics Laboratories, Inc.
7003 Woodway Dr., Suite 315
Waco,  TX  76712
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/26/1996
Decision Date 08/06/1997
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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