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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 K130919
Device Name SENSUS
Applicant
NEUROMETRIX, INC.
62 FOURTH AVE.
WALTHAM,  MA  02451
Applicant Contact RAINER MAAS
Correspondent
NEUROMETRIX, INC.
62 FOURTH AVE.
WALTHAM,  MA  02451
Correspondent Contact RAINER MAAS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/03/2013
Decision Date 07/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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