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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
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