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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K142355
Device Name Vaginal Tactile Imager
Applicant
Advanced Tactile Imaging, Inc.
1459 Lower Ferry Raod
Trenton,  NJ  08618
Applicant Contact Vladimir Egorov
Correspondent
Advanced Tactile Imaging, Inc.
1459 Lower Ferry Raod
Trenton,  NJ  08618
Correspondent Contact Vladimir Egorov
Regulation Number884.1425
Classification Product Code
HIR  
Date Received08/25/2014
Decision Date 05/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT01111916
NCT01491334
NCT01848626
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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