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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 K030564
Device Name THERMOSKIN CONDUCTIVE PADS
Applicant
United Pacific, Inc.
400 Northeast Dr., Unit F
20/21 Business Center, Unit F
Columbia,  SC  29203
Applicant Contact KEVIN OUTRED
Correspondent
United Pacific, Inc.
400 Northeast Dr., Unit F
20/21 Business Center, Unit F
Columbia,  SC  29203
Correspondent Contact KEVIN OUTRED
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/21/2003
Decision Date 09/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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