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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 K864956
Device Name DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
Applicant
La Jolla Technology, Inc.
11558 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact BALNAVE, PH.D.
Correspondent
La Jolla Technology, Inc.
11558 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact BALNAVE, PH.D.
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/18/1986
Decision Date 03/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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