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FDA 510(k) Application Details - K143711
Device Classification Name
Cuff, Nerve
More FDA Info for this Device
510(K) Number
K143711
Device Name
Cuff, Nerve
Applicant
MEDOVENT GMBH
FRIEDRICH-KOENIG-STR. 3
MAINZ 55129 DE
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Contact
THOMAS FREIER
Other 510(k) Applications for this Contact
Regulation Number
882.5275
More FDA Info for this Regulation Number
Classification Product Code
JXI
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More FDA Info for this Product Code
Date Received
12/29/2014
Decision Date
12/02/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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