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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 K031614
Device Name MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
Applicant
MEDELA, INC.
1101 CORPORATE DR.
MCHENRY,  IL  60050 -7005
Applicant Contact CHRISTOPHER L PETERSON
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/23/2003
Decision Date 06/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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