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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 K872704
Device Name AMASTIM 2000
Applicant
AMATECH INTERNATIONAL, INC.
2400 CENTRAL PARKWAY, STE. K
HOUSTON,  TX  77092
Applicant Contact JERRY Y PARK
Correspondent
AMATECH INTERNATIONAL, INC.
2400 CENTRAL PARKWAY, STE. K
HOUSTON,  TX  77092
Correspondent Contact JERRY Y PARK
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/07/1987
Decision Date 01/22/1988
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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