DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS

Electrode, Cutaneous

LABELTAPE MEDITECT, INC.

The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Disposable, Pin-conn. Polymer-gel Elect. For Tens.

Pre-market Notification Details

Device IDK871026
510k NumberK871026
Device Name:DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS
ClassificationElectrode, Cutaneous
Applicant LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids,  MI  49508
ContactMichael S Bartlett
CorrespondentMichael S Bartlett
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 Received1987-03-16
Decision Date1987-04-22

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