FDA 510(k) Application Details - K021368

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

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510(K) Number K021368
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant MEDELA AG
LAETTICHSTRASSE 4
CH-6340 BAAR CH
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Contact RERNER FREI
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 04/30/2002
Decision Date 05/15/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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