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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
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