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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 K203570
Device Name Mya Joy PLUS Breast Pump
Applicant
Ameda, Inc.
485 Half Day Road; Suite 320
Buffalo Grove,  IL  60089
Applicant Contact Carolin Archibald
Correspondent
Ameda, Inc.
485 Half Day Road; Suite 320
Buffalo Grove,  IL  60089
Correspondent Contact Sean GM Pettibone
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/07/2020
Decision Date 04/22/2021
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
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