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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
510(k) Number K103103
Device Name PRESSON ELECTRODE
Applicant
Persyst Development Corp.
3177 Clearwater Dr.
Prescott,  AZ  86305
Applicant Contact SCOTT B WILSON
Correspondent
Persyst Development Corp.
3177 Clearwater Dr.
Prescott,  AZ  86305
Correspondent Contact SCOTT B WILSON
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received10/20/2010
Decision Date 12/08/2011
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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