FDA 510(k) Application Details - K070412

Device Classification Name

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510(K) Number K070412
Device Name ELEXOMA MEDIC
Applicant REDPLANE AG
BAARERSTRASSE 8
ZUG 6300 CH
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Contact JAEN LABUSCHAGNE
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Regulation Number

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Classification Product Code QJQ
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Date Received 02/12/2007
Decision Date 05/21/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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