FDA 510(k) Application Details - K151661

Device Classification Name	Bit, Drill   More FDA Info for this Device
510(K) Number	K151661
Device Name	Bit, Drill
Applicant	Renovo Life LLC 1104 Spruce Street Belmont, NC 28012 US Other 510(k) Applications for this Company
Contact	Harold Crowder Other 510(k) Applications for this Contact
Regulation Number	888.4540   More FDA Info for this Regulation Number
Classification Product Code	HTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2015
Decision Date	01/15/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review