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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 K231875
Device Name Vaginal Tactile Ultrasound Imager
Applicant
Advanced Tactile Imaging Inc.
1457 Lower Ferry Rd
Ewing,  NJ  08618
Applicant Contact Brendan Francy
Correspondent
Advanced Tactile Imaging Inc.
1457 Lower Ferry Rd
Ewing,  NJ  08618
Correspondent Contact Vladimir Egorov
Regulation Number884.1425
Classification Product Code
HIR  
Subsequent Product Codes
IYN   IYO  
Date Received06/26/2023
Decision Date 02/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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