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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 K020518
Device Name MEDELA SYMPHONY BREAST PUMP, MODEL 024
Applicant
MEDELA, INC.
LAETTICHSTRASSE 4B
BAAR, ZUG,,  CH 6341
Applicant Contact WERNER FREI
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/19/2002
Decision Date 03/07/2002
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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