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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 K093825
Device Name AMBU NEUROLINE DISPOSABLE INOJECT 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 Received12/14/2009
Decision Date 01/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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