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FDA 510(k) Application Details - K043544
Device Classification Name
Pump, Portable, Aspiration (Manual Or Powered)
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510(K) Number
K043544
Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Applicant
MEDELA AG
LAETTICHSTRASSE 7
BAAR, ZUG 6341 CH
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Contact
WERNER FREI
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Regulation Number
878.4780
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Classification Product Code
BTA
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Date Received
12/23/2004
Decision Date
01/07/2005
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
Y
Expedited Review
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