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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name extractor, vacuum, fetal
510(k) Number K041579
Device Name MEDELA SINGLE USE SILC CUP, MODEL 077.0791
Applicant
MEDELA AG
LAETTICHSTRASSE 4B
BAAR, ZUG,  CH CH-6341
Applicant Contact WERNER FREI
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number884.4340
Classification Product Code
HDB  
Date Received06/14/2004
Decision Date 04/21/2005
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
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