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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 K844307
Device Name EGNELL-LACT B BATTERY-OPERATED BREAST PUMP
Applicant
Egnell, Inc.
135 S. La Salle St.
Chicago,  IL  60603
Applicant Contact JOHN F LEMKER
Correspondent
Egnell, Inc.
135 S. La Salle St.
Chicago,  IL  60603
Correspondent Contact JOHN F LEMKER
Regulation Number884.5160
Classification Product Code
HGX  
Date Received10/29/1984
Decision Date 02/04/1985
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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