FDA 510(k) Application Details - K041579

Device Classification Name Extractor, Vacuum, Fetal

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510(K) Number K041579
Device Name Extractor, Vacuum, Fetal
Applicant MEDELA AG
LAETTICHSTRASSE 4B
BAAR, ZUG CH-6341 CH
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Contact WERNER FREI
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Regulation Number 884.4340

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Classification Product Code HDB
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Date Received 06/14/2004
Decision Date 04/21/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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