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 Other 510(k) Applications for this Company
Contact	JAN NIEUWENHUIS 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	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