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FDA 510(k) Application Details - K050573
Device Classification Name
Cuff, Nerve
More FDA Info for this Device
510(K) Number
K050573
Device Name
Cuff, Nerve
Applicant
Polyganics BV
L.J. ZIELSTRAWEG 1
GRONINGEN 9713-GX NL
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Contact
JAN NIEUWENHUIS
Other 510(k) Applications for this Contact
Regulation Number
882.5275
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Classification Product Code
JXI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/07/2005
Decision Date
05/04/2005
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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