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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 K100385
Device Name NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
Applicant
LUV N' CARE, LTD.
1705. S CAPITOL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Applicant Contact JEAN ASQUITH
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/16/2010
Decision Date 03/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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