ACTIVAPATCH ET IONTOPHORESIS PATCH

Device, Iontophoresis, Other Uses

ACTIVATEK INC.

The following data is part of a premarket notification filed by Activatek Inc. with the FDA for Activapatch Et Iontophoresis Patch.

Pre-market Notification Details

Device IDK132832
510k NumberK132832
Device Name:ACTIVAPATCH ET IONTOPHORESIS PATCH
ClassificationDevice, Iontophoresis, Other Uses
Applicant ACTIVATEK INC. 2734 S. 3600 WEST UNIT F West Valley City,  UT  84119
ContactJamal Yanaki
CorrespondentJamal Yanaki
ACTIVATEK INC. 2734 S. 3600 WEST UNIT F West Valley City,  UT  84119
Product CodeEGJ  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-10
Decision Date2014-02-13
Summary:summary

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