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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cutaneous electrode stimulator for urinary incontinence
510(k) Number K192357
Device Name INNOVO
Applicant
Atlantic Therapeutics Ltd.
Parkmore Business Park West
Galway,  IE H91 NHT7
Applicant Contact Anne-Marie Keenan
Correspondent
Atlantic Therapeutics Ltd.
Parkmore Business Park West
Galway,  IE H91 NHT7
Correspondent Contact Anne-Marie Keenan
Regulation Number876.5330
Classification Product Code
QAJ  
Date Received08/29/2019
Decision Date 01/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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