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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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