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FDA 510(k) Application Details - K032115
Device Classification Name
Cuff, Nerve
More FDA Info for this Device
510(K) Number
K032115
Device Name
Cuff, Nerve
Applicant
Polyganics BV
L.J. ZIELSTRAWEG 1
GRONINGEN 9713-GX NL
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Contact
JAN BART HAK
Other 510(k) Applications for this Contact
Regulation Number
882.5275
More FDA Info for this Regulation Number
Classification Product Code
JXI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/09/2003
Decision Date
10/10/2003
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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