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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 K081279
Device Name PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
Applicant
Transfer Technology
37822 Oxford Dr.
Murrieta,  CA  92562
Applicant Contact JOSEPH J ARBOUR
Correspondent
Transfer Technology
37822 Oxford Dr.
Murrieta,  CA  92562
Correspondent Contact JOSEPH J ARBOUR
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/06/2008
Decision Date 01/23/2009
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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