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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 K182749
Device Name Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
Applicant
Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd
Sti.
10006 sok. No: 64 AOSB
Cigli,  TR 35620
Applicant Contact Lindsay Ewers
Correspondent
Lansinoh Laboratories
333 N Fairfax St Ste 400
Alexandria,  VA  22314
Correspondent Contact Lindsay Ewers
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/28/2018
Decision Date 06/12/2019
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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