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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 K161266
FOIA Releasable 510(k) K161266
Device Name Athena Breast Pump
Applicant
EXPLORAMED NC7, INC
2639A TERMINAL BLVD
MOUNTAIN VIEW,  CA  94043
Applicant Contact JOHN CHANG
Correspondent
EXPLORAMED NC7, INC
2639A TERMINAL BLVD
MOUNTAIN VIEW,  CA  94043
Correspondent Contact KERI NG
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/05/2016
Decision Date 08/11/2016
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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