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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 K213913
Device Name leva Pelvic Health System
Applicant
Renovia Inc.
263 Summer St, 5th Floor
Boston,  MA  02210
Applicant Contact Jim O'Connor
Correspondent
Bold Type
2100 N Alafaya Trail
Orlando,  FL  32826
Correspondent Contact Jacqueline Schmainda
Regulation Number884.1425
Classification Product Code
HIR  
Date Received12/15/2021
Decision Date 06/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT04027335
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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