FDA 510(k) Application Details - K043334

Device Classification Name	Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K043334
Device Name	Methyl Methacrylate For Cranioplasty
Applicant	STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. KALAMAZOO, MI 49001 US Other 510(k) Applications for this Company
Contact	WADE T RUTKOSKIE Other 510(k) Applications for this Contact
Regulation Number	882.5300   More FDA Info for this Regulation Number
Classification Product Code	GXP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2004
Decision Date	02/09/2005
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