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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 K950750
Device Name MEDELAS BREAST PUMP
Applicant
Medela, Inc.
4610 Prime Pkwy.
P.O. Box 660
Mchenry,  IL  60050
Applicant Contact STEPHEN D SMITH
Correspondent
Medela, Inc.
4610 Prime Pkwy.
P.O. Box 660
Mchenry,  IL  60050
Correspondent Contact STEPHEN D SMITH
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/17/1995
Decision Date 10/16/1995
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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