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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 K180637
Device Name leva Pelvic Floor Trainer
Applicant
Renovia Inc.
263 Summer St., 5th Floor
Boston,  MA  02210
Applicant Contact Gina Prochillo-Cawston
Correspondent
Renovia Inc.
263 Summer St., 5th Floor
Boston,  MA  02210
Correspondent Contact Gina Prochillo-Cawston
Regulation Number884.1425
Classification Product Code
HIR  
Date Received03/12/2018
Decision Date 04/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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