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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 K172842
Device Name GCE704 Breast Pump
No7 factory European Ind. Park
No. 39 mid Industrial main Rd
Xiaolan Town, Zhongshan City,  CN 528415
Applicant Contact Chiara Cavagnolo
Project mMrketing
112 Caviston Way
Cary,  NC  27519
Correspondent Contact Terrence M. O'Brien
Regulation Number884.5160
Classification Product Code
Date Received09/19/2017
Decision Date 06/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No