SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.

Electrode, Cutaneous

LABELTAPE MEDITECT, INC.

The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Spec T.e.n.s. Prewired Repositionable Tens Elect..

Pre-market Notification Details

Device IDK900656
510k NumberK900656
Device Name:SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.
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 Received1990-02-09
Decision Date1990-03-01

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