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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K072799
Device Name TARGET STERILE ELECTRODE
Applicant
Vision Quest Industries, Inc.
18011 Mitchell So.
Irvine,  CA  92614
Applicant Contact JAIME X PULLEY
Correspondent
Vision Quest Industries, Inc.
18011 Mitchell So.
Irvine,  CA  92614
Correspondent Contact JAIME X PULLEY
Regulation Number882.1320
Classification Product Code
GXY  
Date Received10/01/2007
Decision Date 04/24/2008
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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