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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 K150721
Device Name ARDO Calypso Pro Powered Breast Pump
Applicant
Ardo Medical AG
Gewerbestrasse 19
Unteraegeri,  CH 6314
Applicant Contact ROGER DUBACH
Correspondent
Hogan Lovells US LLP
3 Embarcdero Center, Suite 1500
San Francisco,  CA  94111
Correspondent Contact YARMELA PAVLOVIC
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/19/2015
Decision Date 06/17/2015
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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