PMT TRUSCAN SURFACE ELECTRODE

Electrode, Cutaneous

PMT CORP.

The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt Truscan Surface Electrode.

Pre-market Notification Details

Device IDK122376
510k NumberK122376
Device Name:PMT TRUSCAN SURFACE ELECTRODE
ClassificationElectrode, Cutaneous
Applicant PMT CORP. 1500 PARK RD Chanhassen,  MN  55317
ContactAl Iversen
CorrespondentAl Iversen
PMT CORP. 1500 PARK RD Chanhassen,  MN  55317
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-06
Decision Date2012-12-19
Summary:summary

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