FDA 510(k) Application Details - K162046

Device Classification Name	Lock, Wire, And Ligature, Intraoral   More FDA Info for this Device
510(K) Number	K162046
Device Name	Lock, Wire, And Ligature, Intraoral
Applicant	SUMMIT MEDICAL, INC. 815 NORTHWEST PKWY, STE 100 ST. PAUL, MN 55121 US Other 510(k) Applications for this Company
Contact	Nicole Dove Other 510(k) Applications for this Contact
Regulation Number	872.4600   More FDA Info for this Regulation Number
Classification Product Code	DYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2016
Decision Date	04/11/2017
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