FDA 510(k) Application Details - K053045

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K053045
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 US Other 510(k) Applications for this Company
Contact	DONNA WALLACE 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	10/28/2005
Decision Date	11/21/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review