FDA 510(k) Application Details - K050319

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K050319
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	INTEGRA LIFESCIENCES CORP. 4900 CHARLEMAR DRIVE, BUILDING A CINCINATTI, OH 45227 US Other 510(k) Applications for this Company
Contact	CHARLES E DINKLER II 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	02/09/2005
Decision Date	03/31/2005
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