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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 K942534
Device Name GERBER NATURAL COMFORT BATTERY BREAST PUMP
Applicant
Gerber Products Co.
Gen. Mdse. Div.
728 Booster Blvd.
Reedsburg,  WI  53959
Applicant Contact WENDY VANDUSEN
Correspondent
Gerber Products Co.
Gen. Mdse. Div.
728 Booster Blvd.
Reedsburg,  WI  53959
Correspondent Contact WENDY VANDUSEN
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/27/1994
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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