FDA 510(k) Application Details - K130210

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

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510(K) Number K130210
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant MEDELA AG
LAETTICHSTRASSE 4B
BAAR, ZUG CH-6341 CH
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Contact MARKUS BUETLER
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 01/29/2013
Decision Date 03/15/2013
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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