FDA 510(k) Application Details - K152744

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K152744
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	GYRUS ACMI, INC 136 TURNPIKE ROAD SOUTHBOROUGH, MA 01772 US Other 510(k) Applications for this Company
Contact	DOLAN MILLS Other 510(k) Applications for this Contact
Regulation Number	874.4250   More FDA Info for this Regulation Number
Classification Product Code	ERL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2015
Decision Date	06/10/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review