FDA 510(k) Application Details - K182662

Device Classification Name	More FDA Info for this Device
510(K) Number	K182662
Device Name	NAV PAK Needle, NIM NAV PAK Needle
Applicant	Boston Endo Surgical Tech, Division of Lacey Manufacturing Co., LLC 1146 Barnum Ave Bridgeport, CT 06610 US Other 510(k) Applications for this Company
Contact	James Rogers 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	09/25/2018
Decision Date	04/10/2019
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