FDA 510(k) Application Details - K190715

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K190715
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	Interscope, Inc. 100 Main Street, Suite 108 Whitinsville, MA 01588 US Other 510(k) Applications for this Company
Contact	Jeffery Ryan 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	03/19/2019
Decision Date	12/13/2019
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