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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 K883811
Device Name ELECTRONIC PAIN RELIEVERS
Applicant
Jetco Of America
3003 W. Northern Ave., Ste.
5
Phoenix,  AZ  85051
Applicant Contact L JOHARI
Correspondent
Jetco Of America
3003 W. Northern Ave., Ste.
5
Phoenix,  AZ  85051
Correspondent Contact L JOHARI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/08/1988
Decision Date 10/24/1989
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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