FDA 510(k) Application Details - K162544

Device Classification Name	Handpiece, Rotary Bone Cutting   More FDA Info for this Device
510(K) Number	K162544
Device Name	Handpiece, Rotary Bone Cutting
Applicant	OSTEOMED 3885 ARAPAHO ROAD ADDISON, TX 75001 US Other 510(k) Applications for this Company
Contact	KATHRYN A. JAYNE Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	KMW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2016
Decision Date	04/04/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review