FDA 510(k) Application Details - K153519

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K153519
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	CAREVATURE MEDICAL LTD 42 Tvuot Haarets St. Tel Aviv 6954648 IL Other 510(k) Applications for this Company
Contact	Orly Maor 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	12/08/2015
Decision Date	03/16/2016
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