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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 K210759
Device Name Solo, Swing Maxi
Applicant
Medela, LLC
1101 Corporate Dr.
Mchenry,  IL  60050
Applicant Contact Mike McAndrew
Correspondent
Medela AG
Laettichstrasse 4b
Baar,  CH 6340
Correspondent Contact Jenni Vescovo
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/15/2021
Decision Date 08/11/2021
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
Predetermined Change
Control Plan Authorized		 No
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