FDA 510(k) Application Details - K163322

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K163322
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	TZ MEDICAL INC 17750 SW UPPER BOONES FERRY RD #150 PORTLAND, OR 97224 US Other 510(k) Applications for this Company
Contact	JOHN LUBISICH Other 510(k) Applications for this Contact
Regulation Number	882.4460   More FDA Info for this Regulation Number
Classification Product Code	HBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2016
Decision Date	02/23/2017
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