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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 K191653
Device Name Freestyle Flex
Applicant
Medela AG
Laettichstrasse 4b
Baar Zug,  CH CH-6341
Applicant Contact Judith Bernardo
Correspondent
Hyman, Phelps & McNamara, P.C.
700 Thirteenth Street, N.W., Suite 1200
Washington,  DC  20005
Correspondent Contact Adrienne Lenz
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/20/2019
Decision Date 10/17/2019
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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