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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K041320
Device Name MODIFICATION TO NC-STAT
Applicant
Neurometrix, Inc.
62 Fourth Ave.
Waltham,  MA  02451
Applicant Contact JOSEPH F BURKE
Correspondent
Neurometrix, Inc.
62 Fourth Ave.
Waltham,  MA  02451
Correspondent Contact JOSEPH F BURKE
Regulation Number882.1550
Classification Product Code
JXE  
Date Received05/18/2004
Decision Date 08/12/2004
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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