FDA 510(k) Application Details - K063336

Device Classification Name

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510(K) Number K063336
Device Name MEDELA DOMINANT 50 LIPO, MODEL 600-5706
Applicant MEDELA AG
LAETTICHSTRASSE 4B
BAAR, ZUG CH-6341 CH
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Contact WERNER FREI
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Regulation Number

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Classification Product Code QPB
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Date Received 11/06/2006
Decision Date 02/26/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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