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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 K130349
Device Name FREEMIE BREAST COLLECTION SYSTEM
Applicant
Dao Health
1345 Easy Ln. El Dorado Hills
California,  CA  95762
Applicant Contact DAN GARBEZ
Correspondent
Dao Health
1345 Easy Ln. El Dorado Hills
California,  CA  95762
Correspondent Contact DAN GARBEZ
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/12/2013
Decision Date 09/06/2013
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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