FDA 510(k) Application Details - K193499

Device Classification Name	Driver, Wire, And Bone Drill, Manual   More FDA Info for this Device
510(K) Number	K193499
Device Name	Driver, Wire, And Bone Drill, Manual
Applicant	ProtoMED, Inc. 1329 W 121st Ave Westminster, CO 80234 US Other 510(k) Applications for this Company
Contact	James Jimenez 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	12/17/2019
Decision Date	11/04/2020
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