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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 Hwy. 8
New Brighton,  MN  55112
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
Predetermined Change
Control Plan Authorized		 No
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