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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 K172067
Device Name One Mum Pumpset
Applicant
Ardo medical AG
Gewerbestrasse 19
Unterageri,  CH 6314
Applicant Contact Roger Dubach
Correspondent
Hogan Lovells US LLP
3 Embarcadero Center, Suite 1500
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/07/2017
Decision Date 11/29/2017
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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