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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 K870160
Device Name DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS
Applicant
La Jolla Technology, Inc.
11558 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact BALNAVE, PHD
Correspondent
La Jolla Technology, Inc.
11558 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact BALNAVE, PHD
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/13/1987
Decision Date 04/01/1987
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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