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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 K130210
FOIA Releasable 510(k) K130210
Device Name MEDELA THOPAZ
Applicant
MEDELA AG
LAETTICHSTRASSE 4B
BAAR, ZUG,  CH CH-6341
Applicant Contact MARKUS BUETLER
Correspondent
MEDELA AG
LAETTICHSTRASSE 4B
BAAR, ZUG,  CH CH-6341
Correspondent Contact MARKUS BUETLER
Regulation Number878.4780
Classification Product Code
BTA  
Date Received01/29/2013
Decision Date 03/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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