YARLAP

Stimulator, Electrical, Non-implantable, For Incontinence

INTERNATIONAL TRADE GROUP, INC.

The following data is part of a premarket notification filed by International Trade Group, Inc. with the FDA for Yarlap.

Pre-market Notification Details

Device IDK141643
510k NumberK141643
Device Name:YARLAP
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LN. SUITE O Oxford,  OH  45056
ContactBrent C Reider
CorrespondentBrent C Reider
INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LN. SUITE O Oxford,  OH  45056
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-19
Decision Date2015-04-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860000860000 K141643 000

Trademark Results [YARLAP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
YARLAP
YARLAP
86676589 4895297 Live/Registered
International Trade Group, Inc.
2015-06-28

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