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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 K221476
Device Name Perifit
Applicant
X6 Innovations
128 Rue De La Boétie
Paris,  FR 75008
Applicant Contact Artem Rodionov
Correspondent
Hogan Lovells US, L.L.P.
555 13th St. NW
Washington,  DC  20016
Correspondent Contact Lina Kontos
Regulation Number884.1425
Classification Product Code
HIR  
Date Received05/20/2022
Decision Date 02/10/2023
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
Predetermined Change
Control Plan Authorized		 No
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