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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K043544
Device Name MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
Applicant
MEDELA AG
LAETTICHSTRASSE 7
BAAR, ZUG,  CH 6341
Applicant Contact WERNER FREI
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number878.4780
Classification Product Code
BTA  
Date Received12/23/2004
Decision Date 01/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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