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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 K844013
Device Name CARE ELECTRIC BREAST PUMP
Applicant
Hankscraft Div. of Gerber Products Co.
P.O. Box 120
Reedshurg,  WI  53959
Applicant Contact LEN GRIFFIN
Correspondent
Hankscraft Div. of Gerber Products Co.
P.O. Box 120
Reedshurg,  WI  53959
Correspondent Contact LEN GRIFFIN
Regulation Number884.5160
Classification Product Code
HGX  
Date Received10/12/1984
Decision Date 02/15/1985
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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