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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 K242125
Device Name Elvie Stride 2
Applicant
Chiaro Technology, Ltd.
63-66 Hatton Garden
London,  GB
Applicant Contact Amelia Ortiz Rios
Correspondent
Chiaro Technology, Ltd.
63-66 Hatton Garden
London,  GB
Correspondent Contact Amelia Ortiz Rios
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/19/2024
Decision Date 09/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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