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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 K190810
Device Name OPERA, OPERA eco
Applicant
Unimom Co.
110-19, Gajangsaneopseobuk-ro
Osan-si,  KR 18102
Applicant Contact Sang-Hyun Hong
Correspondent
Unimom Co.
110-19, Gajangsaneopseobuk-ro
Osan-si,  KR 18102
Correspondent Contact Sang-Hyun Hong
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/29/2019
Decision Date 08/30/2019
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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