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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 K122376
Model 2305 SERIES
Device Name PMT TRUSCAN SURFACE ELECTRODE
Original Applicant
PMT CORP.
1500 park rd
chanhassen,  MN  55317
Original Contact al iversen
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/06/2012
Decision Date 12/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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