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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 K192270
Device Name LEva Pelvic Digital Health System
Applicant
Renovia Inc.
263 Summer St., 5th Floor
Boston,  MA  02210
Applicant Contact Gina Prochilo-Cawston
Correspondent
Renovia Inc.
263 Summer St., 5th Floor
Boston,  MA  02210
Correspondent Contact Gina Prochilo-Cawston
Regulation Number884.1425
Classification Product Code
HIR  
Date Received08/22/2019
Decision Date 11/22/2019
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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