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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 K122474
Device Name LANSINOH POWERED ELECTRIC BREAST PUMP
Applicant
Lansinoh Laboratories Saglik Gerecleri Tasarim San
13417 Quivas St.
Westminster,  CO  80234
Applicant Contact Calley Herzog
Correspondent
Lansinoh Laboratories Saglik Gerecleri Tasarim San
13417 Quivas St.
Westminster,  CO  80234
Correspondent Contact Calley Herzog
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/14/2012
Decision Date 12/28/2012
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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