FDA 510(k) Application Details - K140369

Device Classification Name	Neurosurgical Paddie   More FDA Info for this Device
510(K) Number	K140369
Device Name	Neurosurgical Paddie
Applicant	MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE MUNDELEIN, IL 60006 US Other 510(k) Applications for this Company
Contact	MATT CLAUSEN Other 510(k) Applications for this Contact
Regulation Number	882.4700   More FDA Info for this Regulation Number
Classification Product Code	HBA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2014
Decision Date	09/26/2014
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