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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 K222726
Device Name Smartpump 3.0 Double Electric Breast 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 Received09/08/2022
Decision Date 12/23/2022
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
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