FDA 510(k) Application Details - K033395

Device Classification Name	Strip, Craniosynostosis, Preformed   More FDA Info for this Device
510(K) Number	K033395
Device Name	Strip, Craniosynostosis, Preformed
Applicant	Codman & Shurtleff, Inc. 325 PARAMOUNT DR. RAYNHAM, MA 02767-0350 US Other 510(k) Applications for this Company
Contact	LIZ DOLAN Other 510(k) Applications for this Contact
Regulation Number	882.5900   More FDA Info for this Regulation Number
Classification Product Code	GXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2003
Decision Date	02/25/2004
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