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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 K212773
Device Name ARDO Alyssa
Applicant
ARDO Medical AG
Gewerbestrasse 19
Unteraegeri,  CH 6314
Applicant Contact Thomas Schlieper
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact Kristin Zielinski Duggan
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/31/2021
Decision Date 04/15/2022
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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