FDA 510(k) Application Details - K123589

Device Classification Name	More FDA Info for this Device
510(K) Number	K123589
Device Name	CADWELL DISPOSABLE PROBE HANDLE
Applicant	CADWELL 909 N. KELLOGG ST. KENNEWICK, WA 99336 US Other 510(k) Applications for this Company
Contact	CHRIS BOLKAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2012
Decision Date	03/19/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review