ELECTRODE USING PROMEON RG-60 SERIES GEL

Electrode, Cutaneous

LABELTAPE MEDITECT, INC.

The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Electrode Using Promeon Rg-60 Series Gel.

Pre-market Notification Details

Device IDK915333
510k NumberK915333
Device Name:ELECTRODE USING PROMEON RG-60 SERIES GEL
ClassificationElectrode, Cutaneous
Applicant LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids,  MI  49508
ContactLora L.jones
CorrespondentLora L.jones
LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids,  MI  49508
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-26
Decision Date1992-01-14

NIH GUDID Devices

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