FDA 510(k) Application Details - K183545

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K183545
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410 US Other 510(k) Applications for this Company
Contact	Tamara J. West Other 510(k) Applications for this Contact
Regulation Number	882.4310   More FDA Info for this Regulation Number
Classification Product Code	HBE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2018
Decision Date	07/19/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review