FDA 510(k) Application Details - K971408

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K971408
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	IKONOS CORP. 320 S.W. 6TH. AVE., 2ND. FL. PORTLAND, OR 97204 US Other 510(k) Applications for this Company
Contact	CHARLES ALBERT Other 510(k) Applications for this Contact
Regulation Number	882.5330   More FDA Info for this Regulation Number
Classification Product Code	GXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/1997
Decision Date	05/12/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review