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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 K052047
Device Name ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
Applicant
AVENT AMERICA, INC.
1 SPEEN STREET
SUITE 160
FRAMINGHAM,  MA  01701
Applicant Contact RICHARD MORRONEY
Correspondent
AVENT AMERICA, INC.
1 SPEEN STREET
SUITE 160
FRAMINGHAM,  MA  01701
Correspondent Contact RICHARD MORRONEY
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/29/2005
Decision Date 09/22/2005
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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