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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 K043098
Device Name GERBER DOUBLE ELECTRIC BREAST PUMP
Applicant
GERBER PRODUCTS CO.
445 STATE ST.
FREMONT,  MI  49413
Applicant Contact RANGA RANGANATHAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/09/2004
Decision Date 12/15/2004
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
Predetermined Change
Control Plan Authorized		 No
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