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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
Predetermined Change
Control Plan Authorized		 No
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