FDA 510(k) Application Details - K131304

Device Classification Name	More FDA Info for this Device
510(K) Number	K131304
Device Name	SENTIO MMG
Applicant	INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") 21520 BRIDGE STREET SOUTHFIELD, MI 48033 US Other 510(k) Applications for this Company
Contact	AASHISH SHAH 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	05/07/2013
Decision Date	05/29/2014
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