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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K854204
Device Name DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS
Applicant
La Jolla Technology, Inc.
11558 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact THEODORE B HILL
Correspondent
La Jolla Technology, Inc.
11558 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact THEODORE B HILL
Regulation Number882.1320
Classification Product Code
GXY  
Date Received10/16/1985
Decision Date 01/10/1986
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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