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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 K875300
Device Name MEDELA BREAST-PUMP LACTINA
Applicant
Medela, Inc.
C/O Burditt & Radzius
333 W. Wacker Dr., Suite 2600
Chicago,  IL  60606
Applicant Contact JOHN F LEMKER
Correspondent
Medela, Inc.
C/O Burditt & Radzius
333 W. Wacker Dr., Suite 2600
Chicago,  IL  60606
Correspondent Contact JOHN F LEMKER
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/29/1987
Decision Date 04/06/1988
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
Recalls CDRH Recalls
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