FDA 510(k) Application Details - K121606

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K121606
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	KLS-MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH JACKSONVILLE, FL 32246 US Other 510(k) Applications for this Company
Contact	JENNIFER DAMATO Other 510(k) Applications for this Contact
Regulation Number	882.5320   More FDA Info for this Regulation Number
Classification Product Code	GWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2012
Decision Date	01/17/2013
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