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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 K230469
Device Name Compact Wearable Pump
Applicant
Lansinoh Laboratories
99 Canal Center Plaza, Suite 550
Alexandria,  VA  22314
Applicant Contact Lindsay Ewers
Correspondent
Lansinoh Laboratories
99 Canal Center Plaza, Suite 550
Alexandria,  VA  22314
Correspondent Contact Lindsay Ewers
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/21/2023
Decision Date 06/30/2023
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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