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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, Battery-Powered
510(k) Number K091155
Device Name ASCEND
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 Number868.2775
Classification Product Code
BXN  
Date Received04/21/2009
Decision Date 09/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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