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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 K120516
Device Name LONG LIFE PADTM
Original Applicant
OMRON HEALTHCARE, INC.
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/21/2012
Decision Date 05/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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