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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 K961749
Device Name TRANSAMERICA ELECTRODE
Applicant
TRANSAMERICA MEDICAL SYSTEMS
29 COLLEGE ST.
SOUTH HADLEY,  MA  01075
Applicant Contact JOHN F DUNN
Correspondent
TRANSAMERICA MEDICAL SYSTEMS
29 COLLEGE ST.
SOUTH HADLEY,  MA  01075
Correspondent Contact JOHN F DUNN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/25/1996
Decision Date 06/21/1996
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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