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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K231785
Device Name Perifit Pump
Applicant
X6 Innovations
128 Rue La Boétie
Paris,  FR 75008
Applicant Contact Artem Rodionov
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact Lina Kontos
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/20/2023
Decision Date 01/26/2024
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
Predetermined Change
Control Plan Authorized		 No
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