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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 K896620
Device Name NEUROTENS
Applicant
HENLEY INTL.
104 INDUSTRIAL BLVD.,
SUGAR LAND,  TX  77470
Applicant Contact ERNEST J HENLEY,PHD
Correspondent
HENLEY INTL.
104 INDUSTRIAL BLVD.,
SUGAR LAND,  TX  77470
Correspondent Contact ERNEST J HENLEY,PHD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/21/1989
Decision Date 04/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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