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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 K150499
FOIA Releasable 510(k) K150499
Device Name Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
Applicant
MEDELA AG
LATTICHSTRASSE 4B
BAAR,  CH 6341
Applicant Contact ORLANDO ANTUNES
Correspondent
PATHWAY REGULATORY CONSULTING, LLC
W324S3649 COUNTY ROAD E
DOUSMAN,  WI  53118
Correspondent Contact ADRIENNE LENZ
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/26/2015
Decision Date 04/21/2015
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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