MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.

Device, Iontophoresis, Other Uses

LIFE-TECH INTL., INC.

The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Modified Use For Model 6110a Iontophoretic Appli..

Pre-market Notification Details

Device IDK871869
510k NumberK871869
Device Name:MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
ClassificationDevice, Iontophoresis, Other Uses
Applicant LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
ContactCoats, Md
CorrespondentCoats, Md
LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
Product CodeEGJ  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-13
Decision Date1987-08-11

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