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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle, Diagnostic Electromyograph
510(k) Number K071186
Device Name MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
Applicant
Ambu A/S
6740 Baymeadow Dr.
Glen Burnie,  MD  21060
Applicant Contact SANJAY PARIKH
Correspondent
Ambu A/S
6740 Baymeadow Dr.
Glen Burnie,  MD  21060
Correspondent Contact SANJAY PARIKH
Regulation Number890.1385
Classification Product Code
IKT  
Date Received04/30/2007
Decision Date 07/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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