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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 K213311
Device Name Lucy Breast Pump
Applicant
Willow Innovations, Inc.
1975 W El Camino Real, Suite #306
Mountain View,  CA  94040
Applicant Contact Nelson Lam
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number884.5160
Classification Product Code
HGX  
Date Received10/04/2021
Decision Date 02/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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