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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 K191577
Device Name Willow Wearable Breast Pump 2.0
Applicant
Exploramed NC7, Inc.
1975 W. El Camino Real, Suite 306
Mountain View,  CA  94040
Applicant Contact Steve Holmes
Correspondent
Exploramed NC7, Inc.
1975 W. El Camino Real, Suite 306
Mountain View,  CA  94040
Correspondent Contact Steve Holmes
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/14/2019
Decision Date 09/06/2019
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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