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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K140680
Device Name LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
Applicant
Alpine Biomed Aps
Tonsbakken 16 - 18
Skovlunde,  DK DK-2740
Applicant Contact Seamus O'Connor
Correspondent
Alpine Biomed Aps
Tonsbakken 16 - 18
Skovlunde,  DK DK-2740
Correspondent Contact PETER JORGENSEN
Regulation Number882.1330
Classification Product Code
GZL  
Date Received03/18/2014
Decision Date 12/12/2014
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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