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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 K181863
Device Name Elvie Pump
Applicant
Chiaro Technology Limited
2nd Floor 63-66 Hatton Garden
London,  GB EC1N 8LE
Applicant Contact Jonathan O'Toole
Correspondent
Contract In-House Counsel and Consultants, LLC (d/b/a FDA At
53516 Bickett
Chapel Hill,  NC  27517
Correspondent Contact Marc C. Sanchez
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/12/2018
Decision Date 10/10/2018
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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