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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,  CH 6341
Applicant Contact WERNER FREI
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
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
Predetermined Change
Control Plan Authorized		 No
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