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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 K895334
Device Name TTS2600
Applicant
HENLEY INTL.
104 INDUSTRIAL BLVD.,
SUGAR LAND,  TX  77470
Applicant Contact ERNEST HENLEY
Correspondent
HENLEY INTL.
104 INDUSTRIAL BLVD.,
SUGAR LAND,  TX  77470
Correspondent Contact ERNEST HENLEY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/30/1989
Decision Date 10/30/1989
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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