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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 K860772
Device Name HARIKY, MODEL GK-7
Applicant
K-MOT, INC.
7635 NORTH 46TH AVE.
GLENDALE,  AZ  85301
Applicant Contact THOMAS KADOMOTO
Correspondent
K-MOT, INC.
7635 NORTH 46TH AVE.
GLENDALE,  AZ  85301
Correspondent Contact THOMAS KADOMOTO
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/03/1986
Decision Date 05/09/1986
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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