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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 K901344
Device Name MEDELA BATTERY OPERATED BREAST PUMP
Applicant
MEDELA, INC.
C/O BURDITT & RADZIUS
333 WEST WACKER DR., STE. 2600
CHICAGO,  IL  60606
Applicant Contact JOHN F LEMKER
Correspondent
MEDELA, INC.
C/O BURDITT & RADZIUS
333 WEST WACKER DR., STE. 2600
CHICAGO,  IL  60606
Correspondent Contact JOHN F LEMKER
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/22/1990
Decision Date 08/06/1990
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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