FDA 510(k) Application Details - K181241

Device Classification Name	Driver, Wire, And Bone Drill, Manual   More FDA Info for this Device
510(K) Number	K181241
Device Name	Driver, Wire, And Bone Drill, Manual
Applicant	KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 US Other 510(k) Applications for this Company
Contact	Jennifer Damato Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	DZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2018
Decision Date	09/13/2018
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