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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 K161725
Device Name Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
Applicant
Medela, Inc.
1101 Corporate Dr.
Mchenry,  IL  60050
Applicant Contact ROBERT SOKOLOWSKI
Correspondent
Pathway Regulatory Consulting, LLC
W324 S3649 County Rd. E
Dousman,  WI  53118
Correspondent Contact ADRIENNE LENZ
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/22/2016
Decision Date 10/28/2016
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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