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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 K230590
Device Name ARDO Bellis
Applicant
ARDO Medical AG
Gewerbestrasse 19
Unteraegeri,  CH 6314
Applicant Contact Thomas Schlieper
Correspondent
MEDTECH360
Am Wasser 14
Polling,  DE 84570
Correspondent Contact Thomas Reichthalhammer
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/03/2023
Decision Date 03/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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