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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 K173699
Device Name The Pump by Babyation
Applicant
Babyation, LLC
911 Washington Ave.
Suite 427
St. Louis,  MO  63101
Applicant Contact Jared Miller
Correspondent
Acknowledge Regulatory Strategies, LLC
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/04/2017
Decision Date 04/04/2018
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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