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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 K891996
Device Name GERBER PRECIOUS CARE ELECTRIC BREAST PUMP
Applicant
Gerber Products Co.
445 State St.
Fremont,  MI  49413
Applicant Contact ROBERT L LYONS
Correspondent
Gerber Products Co.
445 State St.
Fremont,  MI  49413
Correspondent Contact ROBERT L LYONS
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/28/1989
Decision Date 08/07/1989
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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