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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 K141553
Device Name MEDELA THOPAZ+
Applicant
Medela AG
Laettichstrasse 7b
Baar, Zug,  CH 6341
Applicant Contact ORLANDO ANTUNES
Correspondent
Medela AG
Laettichstrasse 7b
Baar, Zug,  CH 6341
Correspondent Contact ORLANDO ANTUNES
Regulation Number878.4780
Classification Product Code
BTA  
Date Received06/11/2014
Decision Date 08/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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