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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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