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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 K081932
Device Name ENDEARE BREAST PUMP
Applicant
HYGEIA MEDICAL, INC.
6353 CORTE DEL ABETO
SUITE 102
CARLSBAD,  CA  92011
Applicant Contact JASPER BENKE
Correspondent
HYGEIA MEDICAL, INC.
6353 CORTE DEL ABETO
SUITE 102
CARLSBAD,  CA  92011
Correspondent Contact JASPER BENKE
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/07/2008
Decision Date 01/22/2009
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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